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AVITA Medical Limited Proposed Redomiciliation to the United States of America – Scheme Meeting on Monday, 15 June 2020 at 9.00am (AEST) – Business…

Posted: June 10, 2020 at 8:47 am

VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--AVITA Medical Limited ACN 058 466 523 (Company) is pleased to confirm that the general meeting to consider a resolution to approve the proposed scheme of arrangement to effect a redomiciliation of the Company and its subsidiaries from Australia to the United States of America (Scheme Meeting) is being held by way of live webcast at 9.00am (AEST) on Monday, 15 June 2020 (being 7.00pm (EDT) on Sunday, 14 June 2020).

The Scheme Booklet prepared in relation to the proposed scheme of arrangement was despatched (by post or electronically) to Company shareholders on 14 May 2020. A copy of the Scheme Booklet can also be found on the Companys website (https://avitamedical.com/virtual-shareholders-meeting).

The Notice of Scheme Meeting is contained in Appendix F of the Scheme Booklet.

Shareholders are reminded that due to the restrictions imposed by the Australian government in response to the COVID-19 pandemic, the Scheme Meeting is being held exclusively as a virtual meeting by way of the live webcast.

Taking part in the live webcast will enable shareholders to listen to the Scheme Meeting live and view slides and proxy results. Shareholders who are registered as at 9.00am (AEST) on 13 June 2020 will be entitled to ask questions and cast their vote at the appropriate times whilst the Scheme Meeting is in progress. Holders of American Depositary Shares (ADS Holders) are able to listen to the live webcast, however, will not be able to ask questions or vote via the live webcast.

The Company will also provide a brief corporate update to shareholders at the conclusion of the Scheme Meeting.

Shareholders can access the live webcast by following the instructions below.

Participating in the Scheme Meeting

Shareholders are invited to participate in the Scheme Meeting by way of the live webcast on two available platforms:

Once you have accessed the Lumi platform on your web browser or mobile device, you will be prompted to enter the meeting ID, which is: 316-817-384.

Your username is your SRN / HIN (which can be found towards the top right hand corner of your holding statement and on shareholder communications).

Your password is the postcode registered to your holding if you are a shareholder in Australia. If you are a shareholder outside of Australia, your password is your three letter country code (for example, USA for United States of America). A full list of country codes is provided in the attached Scheme Meeting User Guide.

ADS Holders are able to listen to the live webcast of the Scheme Meeting as a visitor by selecting the guest option after entering the meeting ID.

Further details and instructions on how to participate in the Scheme Meeting are contained in the Scheme Meeting User Guide, and on the Companys website (https://avitamedical.com/virtual-shareholders-meeting).

Voting by Proxy

Shareholders who are unable to take part in the Scheme Meeting by way of the live webcast, or choose not to do so, are encouraged to submit their votes by proxy by no later than 9.00am (AEST) on 13 June 2020. Details on how to appoint a proxy are set out in section 3.8 of the Scheme Booklet.

Update details with the Companys share registry

Shareholders are encouraged to update their details with the Companys share registry, Computershare Investor Services Pty Ltd (Computershare), by accessing Computershares website (www.computershare.com.au/easyupdate/avh) to ensure that payment instructions are up-to-date in advance of the anticipated implementation date of the proposed scheme of arrangement.

Authorised for release by the Chief Financial Officer of AVITA Medical Limited.

ABOUT AVITA MEDICAL LIMITED

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a RES REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the

INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit http://www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This announcement includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as anticipate, expect, intend, could, may, will, believe, estimate, look forward, forecast, goal, target, project, continue, outlook, guidance, future, other words of similar meaning and the use of future dates. Forward-looking statements in this announcement include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this announcement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this announcement. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this announcement speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

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AVITA Medical Limited Proposed Redomiciliation to the United States of America - Scheme Meeting on Monday, 15 June 2020 at 9.00am (AEST) - Business...

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Regenerative Medicine Market Size, Share, Tools-Applications, Emerging-Trends, 2019 Growth-Projections, Overview, Business-Opportunities, Software,…

Posted: June 10, 2020 at 8:47 am

The Global Regenerative Medicine market report is deep study of the present market dynamics. It consists of the detailed study of current market trends along with the past statistics. The past years are considered as reference to get the predicted data for the forecasted period. Various important factors such as market trends, revenue growth patterns market shares and demand and supply are included in almost all the market research report for every industry. It is very important for the vendors to provide customers with new and improved product/ services in order to gain their loyalty.

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The up-to-date, complete product knowledge, end users, industry growth will drive the profitability and revenue. Regenerative Medicine market report studies the current state of the market to analyse the future opportunities and risks. The report on Regenerative Medicine market, gives an in-depth analysis of Regenerative Medicine market based on aspects that are very important for the market study. Factors like production, market share, revenue rate, regions and key players define a market study start to end. This report gives an overview of market valued in the year 2019 and its growth in the coming years till 2025. It also predicts the CAGR.

Potential consumers, market values, and the future scope for the Regenerative Medicine market are explained thoroughly to the users in this report. The key players of Regenerative Medicine industry, their product portfolio, market share, industry profiles is studied in this report. Adaptation of new ideas and accepting the latest trends are some the reasons for any markets growth. The Global Regenerative Medicine market research report gives the deep understanding about the regions where the market is impactful. It also elaborates the big and small vendors working actively all over the globe.

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The Regenerative Medicine market report covers the production, sales, and revenue of various top players in the global Regenerative Medicine market, therefore enabling customers to achieve thorough information of the competition and henceforth plan accordingly to challenge them head on and grasp the maximum market share. This report is filled with significant statistics and information for the consumers to attain in-depth data of the Regenerative Medicine market and further Regenerative Medicine market growth. The up-to-date, complete product knowledge, end users, industry growth will drive the profitability and revenue. Regenerative Medicine market report studies the current state of the market to analyze the future opportunities and risks. Regenerative Medicine market report provides a 360-degree global market state. Primarily, the report delivers Regenerative Medicine market introduction, overview, market objectives, market definition, scope, and market size valuation.

A systematized methodology is used to make a Report on the Global Regenerative Medicine market. For the analysis of market on the terms of research strategies, these techniques are helpful. All the information about the Products, manufacturers, vendors, customers and much more is covered in research reports. Various important factors such as market trends, revenue growth patterns market shares and demand and supply are included in almost all the market research report for every industry. Adaptation of new ideas and accepting the latest trends are some the reasons for any markets growth. The Global Regenerative Medicine market research report gives the deep understanding about the regions where the market is impactful. It also elaborates the big and small vendors working actively all over the globe.

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Adroit Market Research is an India-based business analytics and consulting company. Our target audience is a wide range of corporations, manufacturing companies, product/technology development institutions and industry associations that require understanding of a markets size, key trends, participants and future outlook of an industry. We intend to become our clients knowledge partner and provide them with valuable market insights to help create opportunities that increase their revenues. We follow a code Explore, Learn and Transform. At our core, we are curious people who love to identify and understand industry patterns, create an insightful study around our findings and churn out money-making roadmaps.

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SANUWAVE Health to Hold Investor Live Webcast on Wednesday, June 10, 2020 – GlobeNewswire

Posted: June 10, 2020 at 8:47 am

SUWANEE, GA, June 09, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc. (OTCQB: SNWV)announced today that the Company will host a live webcast and conference call on Wednesday, June 10, 2020, beginning at 9AM Eastern Time to provide a business update.

Shareholders and other interested parties can participate in the live webcast athttps://www.webcaster4.com/Webcast/Page/2249/35268.

Shareholders and other interested parties can also participate in the conference call by dialing 844-602-0380 (U.S.) or 862-298-0970 (international). Please join the call at least 10 minutes before the start time.

A replay of the webcast and conference call will be available beginning two hours after its completion through June 17, 2020, by dialing 877-481-4010 (U.S.) or 919-882-2331 and entering replay passcode 35268 and a replay of the webcast will be available athttps://www.webcaster4.com/Webcast/Page/2249/35268 until September 10, 2020.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) (www.SANUWAVE.com) is a shockwave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVEs portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the bodys normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE, is US FDA cleared for the treatment of Diabetic Foot Ulcers. The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTrondevice, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotronand orthoPACEdevices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVEs shockwave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Companys ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Companys product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Companys ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Companys periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visitwww.sanuwave.com.

Contact:

Millennium Park Capital LLCChristopher Wynne312-724-7845cwynne@mparkcm.com

SANUWAVE Health, Inc.Kevin Richardson IIChairman of the Board978-922-2447investorrelations@sanuwave.com

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SANUWAVE Health to Hold Investor Live Webcast on Wednesday, June 10, 2020 - GlobeNewswire

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2020 Life Science Venture Capital Funding Roundup for Q1/Q2 in the BioHealth Capital Region – BioBuzz

Posted: June 10, 2020 at 8:47 am

June 9, 2020

This has certainly been a year unlike any other for BioHealth Capital Region (BHCR) life science companies of all sizes and kinds. Just a few months into 2020, the coronavirus pandemic swept the region, seriously disrupting, albeit temporarily, the best laid plans of aspiring founders, entrepreneurs, emerging startups, pre-clinical and more established, larger biohealth organizations in Virginia, Washington, D.C. and Maryland.

No one has escaped the reach of COVID-19 in the BHCR, the rest of the U.S., or around the globe. While this industry continues to be uniquely positioned to weather a storm like this, many were still impacted via delayed clinical trials and having to adjust to near 100% remote work for non-bench role employees. Some areas like Travel Medicine have been hit hard, as most are canceling their 2020 trips. Sadly, even when daily life resembles a new normal, Travel Medicine is likely to have a longer recovery as many organizations have adapted to virtual meetings that will potentially reduce future travel significantly.

The regional life science ecosystem was prepared and pivoted rapidly to not only ensure continued operations, but also to redirect resources, talent and technologies to creating testing, developing COVID-19 therapies and progressing SARS-CoV-2 vaccine candidates.

The BHCR life science community has been remarkably resilient and innovative during this time, for certain, despite myriad challenges caused by COVID-19 across VC funding, the supply chain, and clinical trials, to name just a few.

Despite all of the tumult and turmoil, VC funding deals are still getting done in the BHCR, though perhaps currently on a slightly slower pace and scale. Well see what the second half holds on the VC funding front, but with signs of a slow, steady, and careful reopening afoot in the region, its possible that funding deals will pick back up in the latter half of 2020.

With that, lets take a look at funding deals that were announced in the BHCR in Q1/Q2 of 2020, the year of the pandemic.

Immunomic Therapeutics Incorporated (ITI), located in Rockville, Maryland recently announced it had closed on $61.3M in financing, exceeding its initial fundraising projections by over $11M. The Korean investment group HLB Co., LTD led the financing round, which is just the latest accomplishment for the clinical-stage biotechnology company that launched in 2006.

Read more about CEO Bill Hearls plans for ITI in our recent BioBuzz story, Marylands Immunomic Therapeutics Exceeds Fundraising Goal, Envisions Future IPO.

LifeSprout, a privately-held regenerative medicine company located in Baltimore, Maryland, recently announced the closing of a $28.5M Series A financing round, marking a significant milestone in its history. The round was led by Redmile Group, LLC, with new institutional investors Nexus Management, LP, Emerald Development Managers, LP, and Baltimores Abell Foundation joining the investment group.

You can read more about LifeSprouts story and plans in our recent featured story, Baltimore, Marylands LifeSprout Closes $28.5M Series-A, Looks Toward the Future.

Integrated Biotherapeutics subsidiary IBT Vaccines, which is located in Rockville, Maryland received $3.9M in funding as part of a larger $48M investment in eight companies by Novo Holdings REPAIR Impact Fund.

The funding will be used to advance its advance the development of the IBT-V02 vaccine for Staphylococcus aureus induced recurrent skin and skin structure infections (SSSI), according to the companys press release in early January 2020. At the time of the announcement, the vaccine was in the late clinical development stage and is potentially a first-to-market, multivalent vaccine for antibiotic resistant Staphylococcus aureus.

Vigene Biosciences, which just recently opened its new headquarters in Rockville, Maryland, announced in late March that it had secured institutional investment from Signet Healthcare Partners (Signet), a New York-based growth equity firm specializing in healthcare investments.

Vigene is a leading provider of viral vector products and services used in gene therapy. According to Washington Business Journal reporting, the round was close to $3M.

We wrote about Vigenes new HQ grand opening and its remarkable relationships with the families it serves. You can read Maryland Biotech Opens New Gene Therapy Contract Manufacturing Facility To Support Rapid Growth to learn more.

College Park, Marylands Pathotrak announced it had closed a seed round of $1.2M in mid-May 2020. The company has developed a rapid food test for salmonella and E. coli in food. The companys new test has the potential to cut down food safety test result turnaround times by nearly one full day, which could have a significant positive financial impact on the food industry while improving food safety for companies and consumers.

The Maryland Momentum Fund contributed $150K, the Dingman Angels, which is a program within the Robert H. Smith School of Business at the University of Maryland, invested $310K, and a global life sciences company with a food safety division also invested in pathOtrack.

You can read more here about Pathtracks novel test and the company in a story BioBuzz recently published.

ARMR Systems, a Maryland BioPark-affiliated startup, received seed money from local funding sources to support its hemorrhagic control systems designed to increase the survivability of battlefield trauma when advanced medical support is not immediately available.

The seed funding included a $350,000 joint investment from the University of Maryland, Baltimore, and the Maryland Momentum Fund and also included funding from the Tamiami Angel Fund.

ARMR Systems was featured in the BioBuzz story, Baltimores Top 10 BioHealth Startup CEOs.

There were several large HealthTech investments in this first half of the year that include:

Timonium, Marylands b.well Connected Health secured $16M in Series A financing to back its patient-facing health management tool. The round was led by UnityPoint Health Ventures, with participation from ThedaCare and Well Ventures.

B.wells management tool integrates data, insights, and partners into a single customized solution that helps people take control of their healthcare experience, according to the companys website. The company is located at The Grid, which is located at the Lion Brothers Building one block south of the University of Maryland Biopark. The company will use the Series A funding to scale as it enters a growth and hiring phase.

Bethesda, Marylands Aledade, a data analytics and healthcare practice workflow company, closed a $64M Series C round led by OMERS Growth Equity. California Medical Association, Echo Health Ventures, and Meritech Capital and GV also contributed to the round. Aledade has created a network of approximately 550 doctor-led Accountable Care Organizations (AOC) that utilize an outcome-based rather than a fee for service business model. The company plans to use the Series C funding to expand its U.S. footprint and AOC practice network.

In the first half of 2020, the resilient nature of the BioHealth Capital Region has been on full display, yet a sobering reality exists: we still dont have a COVID-19 vaccine. And while many companies around the world and region work day and night to create one, the region must remain diligent and smart in how it continues to weather this storm. The second half of 2020 will be interesting to watch, as the region slowly and carefully reopens to a new COVID-19 normal.

If the transition to the post COVID-19 environment goes well, will VC firms come off the sidelines in droves, releasing a flood of new funding? Will companies move forward with M&A thats been held close and delayed? Will a BioHealth Capital Region life science company be the first to get COVID-19 vaccine approved and manufactured? Its difficult to answer any of these questions, but it is certain that Q3/Q4 of 2020 will be fascinating to watch.

Steve has over 20 years experience in copywriting, developing brand messaging and creating marketing strategies across a wide range of industries, including the biopharmaceutical, senior living, commercial real estate, IT and renewable energy sectors, among others. He is currently the Principal/Owner of StoryCore, a Frederick, Maryland-based content creation and execution consultancy focused on telling the unique stories of Maryland organizations.

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Regenerative Medicine Market with Future Prospects, Key Player SWOT Analysis an – News by aeresearch

Posted: June 10, 2020 at 8:47 am

The research report on Regenerative Medicine market provides with a granular evaluation of the business space and contains information regarding the market tendencies such as the prevailing remuneration, revenue estimations, market valuation and market size during the estimated timeframe.

An overview of the performance assessment of the Regenerative Medicine market is mentioned in the report. The document also comprises of insights pertaining to the major market trends and its predicted growth rate. Additional details such as growth avenues as well as hindering factors for this industry landscape are enlisted.

COVID-19, the disease it causes, surfaced in late 2019, and now had become a full-blown crisis worldwide. Over fifty key countries had declared a national emergency to combat coronavirus. With cases spreading, and the epicentre of the outbreak shifting to Europe, North America, India and Latin America, life in these regions has been upended the way it had been in Asia earlier in the developing crisis. As the coronavirus pandemic has worsened, the entertainment industry has been upended along with most every other facet of life. As experts work toward a better understanding, the world shudders in fear of the unknown, a worry that has rocked global financial markets, leading to daily volatility in the U.S. stock markets.

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Regenerative Medicine Market with Future Prospects, Key Player SWOT Analysis an - News by aeresearch

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Orthocell adds to quality of board through appointment of new executive director – Proactive Investors UK

Posted: June 10, 2020 at 8:47 am

With a leading regenerative medicine portfolio and experienced senior advisory team, Orthocell is well-positioned to drive its products into the US, EU and AU markets.

() has enhanced the quality of its board through the appointment ofexperienced medical technology executive Leslie Wise, JD, as an executive director.

A point of strength for the Perth-based regenerative medicine company is the quality of advisors on its board and the key opinion leaders with whom they are closely connected, who are central to the way they innovate and do business.

As such,Wise, who has more than 20 years of specialist experience working in US reimbursement, life scienceand medtech fields, willstrengthen the company's strategy.

Orthocell managing director Paul Anderson said Wise was ideally suited to support the next phase of the companys development.

He said: We are delighted to welcome Leslie to the Orthocell board.

"Leslie has extensive experience in securing US market access and reimbursement for medical devices as well as serving in various senior management positions across large US medical device and pharmaceutical companies.

Leslies depth of knowledge and expertise is ideally suited to our product range and the next phase of growth for Orthocell.

Wise said: I am very excited to be joining Orthocell at this pivotal stage in the companys development.

Orthocell has one of the most advanced musculoskeletal regenerative medicine portfolios globally and is poised to leverage its impressive clinical evidence to drive towards the US, EU and AUS markets.

The timing could not be better for Orthocell as the broader Orthopaedic sector moves towards biologics and minimally invasive surgeries to deliver higher quality, more efficient and cost-effective solutions.

Leslie Wise, JD,has more than 20 years of specialist experience working in US reimbursement, life scienceand medtech fields

Wise has worked for both medical device and pharmaceutical companies, including Bristol Myers-Squib, Sanofi, Biomet Orthopedics and AngioDynamics, and is currently principal of EvidenceMatters, a Global Market Access consultancy.

Her skill set includes reimbursement, value evidence generation, clinical research strategy and frontline regulatory and payer experience, she has demonstrated experience in strategically integrating outcomes research, health policy analysis, payer insight, patient preference, along with stakeholder engagement and has been instrumental in creating new standards for reimbursement in the medtech space.

In recognition of her expertise, Wise was re-appointed to the Medicare Evidence Development Coverage and Advisory Committee (MEDCAC) for 2018-2020 and She also partnered with Advamed to facilitate the MedTech Value Summit inaugural event in Minneapolis in 2019.

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SANUWAVE Health Enters Into Exclusive Letter of Intent to Acquire Celularity’s UltraMIST and Exclusive Partnership Rights for Wound Care Biologic…

Posted: June 10, 2020 at 8:47 am

Contemplated Transaction Would Create a Leading Provider of Advanced Wound Care Solutions that Improve Clinical Outcomes Across the Continuum of Care

SUWANEE, GA, June 10, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc.(OTCQB: SNWV)today announced that it has entered into an exclusive, non-binding letter of intent to acquire Celularitys UltraMIST Ultrasound Healing Therapy asset as well as exclusive partnership rights for Celularitys wound care biologic products. Celularity is a privately held, clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies, engineered from the postpartum human placenta, in cancer, infectious disease, and degenerative disease. SANUWAVE will conduct an investor teleconference at 9:00 a.m. EDT today to discuss how the contemplated acquisition is expected to broaden its wound care portfolio and enhance its financial profile.

UltraMISTand the Celularity wound care biologic products, Biovance and Interyl, are excellent complements to our dermaPACE System, said Kevin Richardson, SANUWAVE Chief Executive Officer. The contemplated acquisition would bolster our advance wound care portfolio and support our growth strategy to offer comprehensive advanced wound care solutions to improve clinical outcomes across the care pathway. The UltraMIST device is already established in over 900 wound care clinics and SANUWAVE will leverage their sales team to accelerate the penetration of dermaPACE into those facilities.

We are excited about the prospect to bring Celularitys wound care technologies and 25 dedicated wound care professionals to our team, Mr. Richardson continued. Together, we will apply shockwave and ultrasound science to bring differentiated offerings to key wound care solutions worldwide.

The transaction is expected to close in July 2020. The funding for the acquisition will consist of a mix of funded term debt and equity. Existing SANUWAVE shareholders, directors and officers have committed over $5 million at $0.25 per share to assist in completing the transaction.

SANUWAVE has engaged William Blair for investment banking services to arrange, negotiate and assist in the placement of debt capital for the proposed acquisition. William Blair is in advanced discussions with lenders for the debt capital.

The contemplated acquisition is expected to be a transformative event for SANUWAVE and to represent a strategically and financially compelling growth opportunity for the Company. The contemplated transaction would broaden SANUWAVEs addressable market and combines two highly complementary energy transfer technologies with two biologic skin substitute products to create a platform of scale with an end-to-end product offering in the advanced wound care market. Furthermore, it would uniquely position SANUWAVE to address the entire advanced wound care patient pathway from the initial stages of treatment to closure. The treatment combination of UltraMIST and the dermaPACE System would create a significant opportunity to demonstrate improved patient outcomes over the current standard of care, initially for diabetic foot ulcers and across all wound indications in the future.

SANUWAVE will conduct an investor teleconference at 9:00 a.m. EDT today. Investors can access this conference via the following:

Live webcast athttps://www.webcaster4.com/Webcast/Page/2249/35268

Live telephone:

Call 844-602-0380 within the U.S. or +1 862-298-0970 outside the U.S. Please join the call at least 10 minutes before the start time.

Webcast replay:

Go tohttps://www.webcaster4.com/Webcast/Page/2249/35268. The webcast replay will be available until Thursday, September 10, 2020.

Telephone replay:

Call 877-481-4010 within the U.S. or +1 919-882-2331 (for both U.S. and outside U.S., the access code is 35268). The telephone replay will be available until Wednesday, June 17, 2020.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) (www.SANUWAVE.com) is a shockwave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVEs portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the bodys normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE, is US FDA cleared for the treatment of Diabetic Foot Ulcers. The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTrondevice, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotronand orthoPACEdevices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVEs shockwave technology for non-medical uses, including energy, water, food and industrial markets.

About Celularity Inc.

Celularity, headquartered in Warren, N.J., is a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies derived from the postpartum human placenta. Using proprietary technology in combination with its IMPACT platform, Celularity is the only company harnessing the purity and versatility of placental-derived cells to develop and manufacture innovative, highly scalable off-the-shelf treatments for patients with cancer, infectious diseases, and degenerative diseases. To learn more, please visitwww.celularity.com.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Companys ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Companys product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Companys ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Companys periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visitwww.sanuwave.com.

Contact:

Millennium Park Capital LLCChristopher Wynne312-724-7845cwynne@mparkcm.com

SANUWAVE Health, Inc.Kevin Richardson IICEO and Chairman of the Board978-922-2447investorrelations@sanuwave.com

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SANUWAVE Health Enters Into Exclusive Letter of Intent to Acquire Celularity's UltraMIST and Exclusive Partnership Rights for Wound Care Biologic...

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Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market 2019 Break Down by Top Companies, Countries, Applications, Challenges,…

Posted: June 10, 2020 at 8:46 am

A new market report by Market Research Intellect on the Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market has been released with reliable information and accurate forecasts for a better understanding of the current and future market scenarios. The report offers an in-depth analysis of the global market, including qualitative and quantitative insights, historical data, and estimated projections about the market size and share in the forecast period. The forecasts mentioned in the report have been acquired by using proven research assumptions and methodologies. Hence, this research study serves as an important depository of the information for every market landscape. The report is segmented on the basis of types, end-users, applications, and regional markets.

The research study includes the latest updates about the COVID-19 impact on the Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) sector. The outbreak has broadly influenced the global economic landscape. The report contains a complete breakdown of the current situation in the ever-evolving business sector and estimates the aftereffects of the outbreak on the overall economy.

Get Sample Copy with TOC of the Report to understand the structure of the complete report @ https://www.marketresearchintellect.com/download-sample/?rid=235171&utm_source=COD&utm_medium=888

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Leading Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) manufacturers/companies operating at both regional and global levels:

Sales and sales broken down by Product:

Sales and sales divided by Applications:

The report also inspects the financial standing of the leading companies, which includes gross profit, revenue generation, sales volume, sales revenue, manufacturing cost, individual growth rate, and other financial ratios.

The report also focuses on the global industry trends, development patterns of industries, governing factors, growth rate, and competitive analysis of the market, growth opportunities, challenges, investment strategies, and forecasts till 2026. The Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market was estimated at USD XX Million/Billion in 2016 and is estimated to reach USD XX Million/Billion by 2026, expanding at a rate of XX% over the forecast period. To calculate the market size, the report provides a thorough analysis of the market by accumulating, studying, and synthesizing primary and secondary data from multiple sources.

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The market is predicted to witness significant growth over the forecast period, owing to the growing consumer awareness about the benefits of Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs). The increase in disposable income across the key geographies has also impacted the market positively. Moreover, factors like urbanization, high population growth, and a growing middle-class population with higher disposable income are also forecasted to drive market growth.

According to the research report, one of the key challenges that might hinder the market growth is the presence of counter fit products. The market is witnessing the entry of a surging number of alternative products that use inferior ingredients.

Key factors influencing market growth:

Reasons for purchasing this Report from Market Research Intellect

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Customization of the Report:

Market Research Intellect also provides customization options to tailor the reports as per client requirements. This report can be personalized to cater to your research needs. Feel free to get in touch with our sales team, who will ensure that you get a report as per your needs.

Thank you for reading this article. You can also get chapter-wise sections or region-wise report coverage for North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

To summarize, the Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) market report studies the contemporary market to forecast the growth prospects, challenges, opportunities, risks, threats, and the trends observed in the market that can either propel or curtail the growth rate of the industry. The market factors impacting the global sector also include provincial trade policies, international trade disputes, entry barriers, and other regulatory restrictions.

About Us:

Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage and more. These reports deliver an in-depth study of the market with industry analysis, market value for regions and countries and trends that are pertinent to the industry.

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Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market 2019 Break Down by Top Companies, Countries, Applications, Challenges,...

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Stem Cells Market 2019 Break Down by Top Companies, Countries, Applications, Challenges, Opportunities and Forecast 2026 – Cole of Duty

Posted: June 10, 2020 at 8:46 am

A new market report by Market Research Intellect on the Stem Cells Market has been released with reliable information and accurate forecasts for a better understanding of the current and future market scenarios. The report offers an in-depth analysis of the global market, including qualitative and quantitative insights, historical data, and estimated projections about the market size and share in the forecast period. The forecasts mentioned in the report have been acquired by using proven research assumptions and methodologies. Hence, this research study serves as an important depository of the information for every market landscape. The report is segmented on the basis of types, end-users, applications, and regional markets.

The research study includes the latest updates about the COVID-19 impact on the Stem Cells sector. The outbreak has broadly influenced the global economic landscape. The report contains a complete breakdown of the current situation in the ever-evolving business sector and estimates the aftereffects of the outbreak on the overall economy.

Get Sample Copy with TOC of the Report to understand the structure of the complete report @ https://www.marketresearchintellect.com/download-sample/?rid=207801&utm_source=COD&utm_medium=888

The report also emphasizes the initiatives undertaken by the companies operating in the market including product innovation, product launches, and technological development to help their organization offer more effective products in the market. It also studies notable business events, including corporate deals, mergers and acquisitions, joint ventures, partnerships, product launches, and brand promotions.

Leading Stem Cells manufacturers/companies operating at both regional and global levels:

Sales and sales broken down by Product:

Sales and sales divided by Applications:

The report also inspects the financial standing of the leading companies, which includes gross profit, revenue generation, sales volume, sales revenue, manufacturing cost, individual growth rate, and other financial ratios.

The report also focuses on the global industry trends, development patterns of industries, governing factors, growth rate, and competitive analysis of the market, growth opportunities, challenges, investment strategies, and forecasts till 2026. The Stem Cells Market was estimated at USD XX Million/Billion in 2016 and is estimated to reach USD XX Million/Billion by 2026, expanding at a rate of XX% over the forecast period. To calculate the market size, the report provides a thorough analysis of the market by accumulating, studying, and synthesizing primary and secondary data from multiple sources.

To get Incredible Discounts on this Premium Report, Click Here @ https://www.marketresearchintellect.com/ask-for-discount/?rid=207801&utm_source=COD&utm_medium=888

The market is predicted to witness significant growth over the forecast period, owing to the growing consumer awareness about the benefits of Stem Cells. The increase in disposable income across the key geographies has also impacted the market positively. Moreover, factors like urbanization, high population growth, and a growing middle-class population with higher disposable income are also forecasted to drive market growth.

According to the research report, one of the key challenges that might hinder the market growth is the presence of counter fit products. The market is witnessing the entry of a surging number of alternative products that use inferior ingredients.

Key factors influencing market growth:

Reasons for purchasing this Report from Market Research Intellect

Customized Research Report Using Corporate Email Id @ https://www.marketresearchintellect.com/need-customization/?rid=207801&utm_source=COD&utm_medium=888

Customization of the Report:

Market Research Intellect also provides customization options to tailor the reports as per client requirements. This report can be personalized to cater to your research needs. Feel free to get in touch with our sales team, who will ensure that you get a report as per your needs.

Thank you for reading this article. You can also get chapter-wise sections or region-wise report coverage for North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

To summarize, the Stem Cells market report studies the contemporary market to forecast the growth prospects, challenges, opportunities, risks, threats, and the trends observed in the market that can either propel or curtail the growth rate of the industry. The market factors impacting the global sector also include provincial trade policies, international trade disputes, entry barriers, and other regulatory restrictions.

About Us:

Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage and more. These reports deliver an in-depth study of the market with industry analysis, market value for regions and countries and trends that are pertinent to the industry.

Contact Us:

Mr. Steven Fernandes

Market Research Intellect

New Jersey ( USA )

Tel: +1-650-781-4080

Read the original:
Stem Cells Market 2019 Break Down by Top Companies, Countries, Applications, Challenges, Opportunities and Forecast 2026 - Cole of Duty

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Genmab Announces European Marketing Authorization for the Subcutaneous Formulation of DARZALEX (daratumumab) for the Treatment of Patients with…

Posted: June 10, 2020 at 8:46 am

Company Announcement

Copenhagen, Denmark; June 4, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for the subcutaneous (SC) formulation of DARZALEX (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved daratumumab intravenous (IV) formulation indications in frontline and relapsed / refractory settings. The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV daratumumab, which is given over several hours. Patients currently on daratumumab IV will have the choice to switch to the SC formulation. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

We are extremely pleased that patients in Europe with multiple myeloma will now, like patients in the U.S., have the opportunity for treatment with the subcutaneous formulation of daratumumab. With consistent efficacy, and greater convenience for patients and health care providers with dosing time reduced from hours to just minutes and fewer infusion-related reactions, this formulation provides significant benefits for patients, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab

The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the SC formulation of daratumumab to the IV formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which is evaluating SC daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and the 24th European Hematology Association (EHA) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61st American Society of Hematology (ASH) Annual Meeting in December 2019.

About the COLUMBA (MMY3012) studyThe Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that included 522 adults diagnosed with relapsed and refractory multiple myeloma. Patients were randomized to receive either: SC daratumumab, as 1800 mg daratumumab with rHuPH20 2000 U/mL once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study; or 16 mg/kg IV daratumumab once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The co-primary endpoints of the study are overall response rate and Maximum trough concentration of daratumumab (Ctrough; defined as the serum pre-dose concentration of daratumumab on Cycle 3 Day 1).

About the PLEIADES (MMY2040) studyThe Phase II trial (NCT03412565) is a non-randomized, open-label, parallel assignment study that includes 265 adults either newly diagnosed or with relapsed or refractory multiple myeloma. Patients with newly diagnosed multiple myeloma are being treated with 1,800 mg SC daratumumab in combination with either bortezomib, lenalidomide and dexamethasone (D-VRd) or bortezomib, melphalan and prednisone (D-VMP). Patients with relapsed or refractory multiple myeloma are being treated with 1,800 mg SC daratumumab plus lenalidomide and dexamethasone (D-Rd). An additional cohort of patients with relapsed and refractory multiple myeloma treated with daratumumab plus carfilzomib and dexamethasone (D-Kd) was subsequently added to the study. The primary endpoint for the D-VMP, D-Kd and D-Rd cohorts is overall response rate. The primary endpoint for the D-VRd cohort is very good partial response or better rate.

About DARZALEX (daratumumab)DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. Daratumumab is the first subcutaneous CD38-directed antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.3 DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,4,5,6,7

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of three approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Arzerra (ofatumumab, under agreement with Novartis AG), for the treatment of certain chronic lymphocytic leukemia indications in the U.S., Japan and certain other territories and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), has been approved in the U.S. for the treatment of adult patients with certain multiple myeloma indications. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development by Novartis for the treatment of relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. Arzerra is a trademark of Novartis AG or its affiliates. DARZALEX and DARZALEX FASPRO are trademarks of Janssen Pharmaceutica NV. TEPEZZA is a trademark of Horizon Therapeutics plc.

1 DARZALEX Prescribing information, April 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s027lbl.pdf Last accessed April 20202 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed October 20193 DARZALEX FASPRO Prescribing information, May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf Last accessed May 20204 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.5Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.6 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.7 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974

Company Announcement no. 24CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab Announces European Marketing Authorization for the Subcutaneous Formulation of DARZALEX (daratumumab) for the Treatment of Patients with...

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