Category Archives: Regenerative Medicine

Agreements Contingent on FTC and European Commission Approval and Completion of AbbVie's Pending Acquisition of Allergan

NORTH CHICAGO, Ill. and DUBLIN, Jan. 27, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, and Allergan (NYSE: AGN), a leading global pharmaceutical company, today announced that Allergan has entered into definitive agreements to divest brazikumab (IL-23 inhibitor) and Zenpep (pancrelipase). These agreements are in conjunction with the ongoing regulatory approval process for AbbVie's acquisition of Allergan.

AstraZeneca (NYSE: AZN) will acquire brazikumab, an investigational IL-23 inhibitor in Phase 2b/3 development for Crohn's Disease and in Phase 2 development for ulcerative colitis, including global development and commercial rights.

Nestle (Swiss: NESN) will acquire and take full operational ownership of Zenpep upon closing the transaction with customary transition support from Allergan. Zenpep is a treatment, which is available in the United States, for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions. Nestle also will be acquiring Viokace, another pancreatic enzyme preparation, as part of the same transaction.

"These definitive agreements represent significant progress toward the completion of our acquisition of Allergan," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "The new combined organization will be well positioned to deliver on our mission to patients with a broad portfolio of innovative therapies."

"Today, we move another step closer to completing AbbVie's acquisition of Allergan. Allergan's commercial and R&D teams have invested so much of themselves into the development of brazikumab and the commercialization of Zenpep, and these divestiture agreements will enable that work to continue following the close of our planned acquisition," said Brent Saunders, chairman and chief executive officer of Allergan.

The closings of the acquisitions of brazikumab and Zenpep are contingent upon receipt of U.S. Federal Trade Commission and European Commission approval, closing of AbbVie's pending acquisition of Allergan and the satisfaction of other customary closing conditions.

On January 10, 2020, AbbVie and Allergan received conditional approval of the transaction by the European Commission, subject to the approved divestiture of brazikumab and other conditions.

AbbVie and Allergan continue to expect a first-quarter 2020 close of their pending transaction, subject to receipt of required regulatory approvals and other closing conditions.

About AbbVieAbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

About Allergan plcAllergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers, and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan's website at http://www.Allergan.com.

About ZenpepZENPEP (pancrelipase) is a prescription medication for people who cannot digest food normally because their pancreas does not make enough enzymes. ZENPEP may help your body use fats, proteins, and sugars from food. ZENPEP contains a mixture of digestive enzymes (lipases, proteases, and amylases) from pig pancreas. In clinical studies, individuals with exocrine pancreatic insufficiency associated with cystic fibrosis absorbed more fat from foods than those treated with a placebo.

About BrazikumabBrazikumab is a monoclonal antibody that binds to the IL23 receptor and is in development for Crohn's Disease and Ulcerative Colitis with a companion biomarker. Brazikumab selectively blocks the IL23 immune signal, preventing intestinal inflammation. The Phase IIb/III INTREPID program is underway to assess brazikumab compared to placebo or adalimumab in Crohn's Disease. The Phase II EXPEDITION trial is underway to assess brazikumab compared to placebo or vedolizumab in Ulcerative Colitis.

Forward-Looking StatementsThis announcement contains certain forward-looking statements, including with respect to the pending acquisition involving AbbVie and Allergan, Allergan's divestitures of brazikumab and Zenpep and AbbVie's, Allergan's and/or the combined group's estimated or anticipated future business, performance and results of operations and financial condition, including estimates, forecasts, targets and plans for AbbVie and, following the acquisition, if completed, the combined group. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the possibility that the divestitures and/or the pending acquisition will not be pursued, failure to obtain necessary regulatory approvals or required financing or to satisfy any of the other conditions to the pending acquisition, adverse effects on the market price of AbbVie's shares of common stock or Allergan's ordinary shares and on AbbVie's or Allergan's operating results because of a failure to complete the pending acquisition, failure to realize the expected benefits of the pending acquisition, failure to promptly and effectively integrate Allergan's businesses, negative effects relating to the announcement of the pending acquisition or any further announcements relating to the pending acquisition or the consummation of the pending acquisition on the market price of AbbVie's shares of common stock or Allergan's ordinary shares, significant transaction costs and/or unknown or inestimable liabilities, potential litigation associated with the pending acquisition, general economic and business conditions that affect the combined companies following the consummation of the pending acquisition, changes in global, political, economic, business, competitive, market and regulatory forces, future exchange and interest rates, changes in tax laws, regulations, rates and policies, future business acquisitions or disposals and competitive developments. These forward-looking statements are based on numerous assumptions and assessments made in light of AbbVie's or, as the case may be, Allergan's experience and perception of historical trends, current conditions, business strategies, operating environment, future developments and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The factors described in the context of such forward-looking statements in this announcement could cause AbbVie's plans with respect to Allergan or AbbVie's or Allergan's actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements. Although it is believed that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct and persons reading this announcement are therefore cautioned not to place undue reliance on these forward-looking statements which speak only as of the date of this announcement. Additional information about economic, competitive, governmental, technological and other factors that may affect AbbVie or Allergan is set forth in AbbVie's and Allergan's periodic public filings with the U.S. Securities and Exchange Commission, including, but not limited to, AbbVie's and Allergan's Annual Report on Form 10-K for the year ended December 31, 2018, Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019, Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2019, Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2019 and, from time to time, AbbVie's and Allergan's other investor communications, in each case, the contents of which are not incorporated by reference into, nor do they form part of, this announcement.

Any forward-looking statements in this announcement are based upon information available to AbbVie, Allergan and/or their respective board of directors, as the case may be, as of the date of this announcement and, while believed to be true when made, may ultimately prove to be incorrect. Subject to any obligations under applicable law, none of AbbVie, Allergan or any member of their respective board of directors undertakes any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations. All subsequent written and oral forward-looking statements attributable to AbbVie, Allergan or their respective board of directors or any person acting on behalf of any of them are expressly qualified in their entirety by this paragraph.

Statement Required by Irish Takeover RulesThe Directors of AbbVie Inc. accept responsibility for the information contained in this announcement. To the best of their knowledge and belief (having taken all reasonable care to ensure such is the case), the information contained in this announcement is in accordance with the facts and does not omit anything likely to affect the import of such information.

The Allergan directors accept responsibility for the information contained in this report. To the best of the knowledge and belief of the Allergan directors (who have taken all reasonable care to ensure such is the case), the information contained in this report for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.

Any holder of 1% or more of any class of relevant securities of Allergan plc or AbbVie Inc. may have disclosure obligations under Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013.

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SOURCE AbbVie

Company Codes: NYSE:ABBV, NYSE:AGN, NYSE:AZN, Swiss:NESN, OTC-PINK:NSRGY

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AbbVie and Allergan Announce Agreements to Divest Brazikumab and Zenpep - BioSpace

DURHAM, N.C. (PRWEB) January 06, 2020

A new, safe and efficient way to coax stem cells into bone cells is reported in a recently published article from STEM CELLS Translational Medicine (SCTM). The protocol, developed by researchers at the University of Sydney, Australian Research Centre (ARC) for Innovative BioEngineering, could lead to a shift in the treatment of bone regenerative medicine.

Large bone defects and loss due to cancer or trauma can result in scar tissue that impairs the bones ability to repair and regenerate. The current gold standard therapy, autografting, has inherent drawbacks, including limited availability and donor site morbidity. This leaves researchers seeking an alternative source of bone cells and makes bone tissue engineering a growing field with considerable translational potential.

The success of induced pluripotent stem cell (iPSC) technology to reprogram fibroblasts into progenitor cells of various lineages offers an exciting route for tissue repair and regeneration, said Zufu Lu, Ph.D., a member of the University of Sydneys Biomaterials and Tissue Engineering Research Unit and a research associate at the ARC for Innovative BioEngineering. He is a co-lead investigator of the SCTM study, along with Professor Hala Zreiqat, Ph.D., head of the research unit and director of the ARC Training Centre for Innovative BioEngineering.

However, while iPSC technology represents a potentially unlimited source of progenitor cells and allows patients to use their own cells for tissue repair and regeneration thus posing little or no risk of immune rejection the technology has several constraints. Among them are the requirement for complex reprogramming using the Yamanaka factors (Oct3/4, Sox2, Klf4, c-Myc). To add to the complexity, specific stimuli are required to direct iPSCs to re-differentiate to progenitor cells of the lineage of interest.

In addition, Dr. Lu said, any remaining iPSCs pose the risk of tumors following implantation.

One potential way around this, as demonstrated by recent studies, is through the direct reprogramming of fibroblasts into bone cells. Fibroblasts are morphologically similar to osteoblasts. Their similar transcriptomic profiles led us to hypothesize that distinct factors produced by osteoblasts may be capable of coaxing fibroblasts to become osteoblast-like cells, Prof. Zreiqat said.

Previous studies aimed at using fibroblasts to produce various cell types relied on the genetic manipulation of one or more transcription regulators. But just as with iPSCs, reprogramming fibroblasts in this manner has its own inherent technical and safety issues. The Lu-Zreiqat team, however, surmised that an approach employing natural factors might just allow better control over reprogramming and improve the safety.

Unlike genetic reprogramming, chemical induction of cell reprogramming is generally rapid and reversible, and is also more amenable to control through factor dosage and/or combinations with other molecules, Dr. Lu explained.

The team initially determined that media conditioned by human osteoblasts can induce reprogramming of human fibroblasts to functional osteoblasts. Next, said Prof. Zreiqat, our proteomic analysis identified a single naturally bioactive protein, insulin growth factor binding protein-7 (IGFBP7), as being significantly elevated in media conditioned with osteoblasts, compared to those with fibroblasts.

This led them to test IGFBP7s ability as a transcription factor. They found it, indeed, successfully induced a switch from fibroblasts to osteoblasts in vitro. They next tested it in a mouse model and once again experienced success when the fibroblasts produced mineralized tissue. The switch was associated with senescence and dependent on autocrine IL-6 signaling.

The approach we describe in our study has significant advantages over other commonly used cell sources including iPSCs and adult mesenchymal stem cells, Dr. Lu and Prof Zreiqat concluded.

Bone tissue engineering is a growing field where cell therapies have considerable translational potential, but current cell-based approaches face limitations, said Anthony Atala, M.D., Editor-in-Chief of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. The novel observation described in this study could potentially lead to a shift in the current paradigm of bone regenerative medicine.

This study was conducted in collaboration with the Charles Perkins Centre and the Childrens Hospital at Westmead, University of Sydney.

The full article, Reprogramming of human fibroblasts into osteoblasts by insulin-like growth factor binding protein 7, can be accessed at https://stemcellsjournals.onlinelibrary.wiley.com/doi/abs/10.1002/sctm.19-0281.

About STEM CELLS Translational Medicine: STEM CELLS Translational Medicine (SCTM), co-published by AlphaMed Press and Wiley, is a monthly peer-reviewed publication dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices. SCTM is the official journal partner of Regenerative Medicine Foundation.

About AlphaMed Press: Established in 1983, AlphaMed Press with offices in Durham, NC, San Francisco, CA, and Belfast, Northern Ireland, publishes two other internationally renowned peer-reviewed journals: STEM CELLS (http://www.StemCells.com), celebrating its 38th year, is the world's first journal devoted to this fast paced field of research. The Oncologist (http://www.TheOncologist.com), also a monthly peer-reviewed publication, entering its 25th year, is devoted to community and hospital-based oncologists and physicians entrusted with cancer patient care. All three journals are premier periodicals with globally recognized editorial boards dedicated to advancing knowledge and education in their focused disciplines.

About Wiley: Wiley, a global company, helps people and organizations develop the skills and knowledge they need to succeed. Our online scientific, technical, medical and scholarly journals, combined with our digital learning, assessment and certification solutions, help universities, learned societies, businesses, governments and individuals increase the academic and professional impact of their work. For more than 200 years, we have delivered consistent performance to our stakeholders. The company's website can be accessed at http://www.wiley.com.

About Regenerative Medicine Foundation (RMF): The non-profit Regenerative Medicine Foundation fosters strategic collaborations to accelerate the development of regenerative medicine to improve health and deliver cures. RMF pursues its mission by producing its flagship World Stem Cell Summit, honouring leaders through the Stem Cell and Regenerative Medicine Action Awards, and promoting educational initiatives.

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New protocol could signal shift in bone regenerative medicine - PR Web

The 2020 World Stem Cell Summit will take place Jan. 21- 24, 2020 in Miami, FL

Washington, DC - (January 2, 2020), Jan. 03, 2020 (GLOBE NEWSWIRE) -- The Regenerative Medicine Foundation (RMF), a not-for-profit organization dedicated tothe advancement of ethical research and patient advocacy for the development ofcurative medicine utilizing advanced cell and gene therapies, today announced thedesignation of four new positions to the Board of Directors. Sam Merchant, founder ofThe Merchants Financial Group, has been elected Board Chair, Dr. Jeanne Fontana asVice Chair, Alan Jakimo Esq. and Dr. Ann Murphy as members at large.Both Sam and Jeanne have taken a great deal of time to understand the role of ourfoundation in accelerating the field of regenerative medicine. Both will take leadershipresponsibility and possess the vision to accomplish our mission. Alan and Ann have longserved as valued collaborators to RMF and I am grateful that they are joining the board,said Bernard Siegel, Executive Director, of the RMF and Founder of the World Stem CellSummit.

Sam Merchant - Sam is the founder of The Merchants Financial Group, a global capitalinvestment corporation focused on identifying and developing international growthopportunities in a variety of business areas including technology, artificial intelligence,biotech, banking, manufacturing, franchising, multiple real estate sectors including butnot limited to R&D and manufacturing lab, healthcare, opportunity zones andunderwriting of financial products including, but not limited to, tax incentive bonds andprivate and public syndicated equity. Mr. Merchant is an active member of the Atlantabusiness community since 1981, and is a US citizen since 1986. He served on theAtlanta Regional Commission Board for seven years and as a stakeholder member ofAtlanta Vision 20/20 commencing in 1990. With family business operations based inAtlanta, GA, and West Palm Beach, FL, Sams expertise in innovative financial solutionsand strategic planning has enabled the expansion of multiple emerging as well asestablished public and private operations throughout the world. Sam has been a SouthFlorida permanent resident for the last few years. He is a co-founder and Chairman ofthe Board of a biotech company, BioCurity Pharmaceuticals Inc. in Jupiter, FL, guidingBioCurity through drug development and company operations. Mr. Merchant is also aco-founder of a boutique investment banking advisory company MerchantCass AdvisorsLLC. Mr. Merchant is proficient and strategic in his understanding and execution of theJOBS Act for the benefit of emerging growth and middle market companies. Hisbusiness and personal interests include traveling the world seeking M&A opportunities,learning more languages, engaging with like-minded ethical, transparent, honestsuccessful people with high morals. He finds pockets of opportunities to make the worlda better place and when the calling came, he gladly accepted the role of Chairman ofBoard of RMF, where he also serves on the executive financial board of the World StemCell Summit. Mr. Merchant is gratified by his ability to give back philanthropically inmultiple regions of the world, where he is known and respected in the communities of allwhose lives he has touched. His quote "pluralism is the key to success for all mankind".

Jeanne Fontana, MD, PhD - As vice chair of RMF, Jeanne brings decades ofexperience in the stem cell community from basic science, to patient advocacy andboard governance. She was an active board member of the Independent CitizensOversight Committee (ICOC) of the California Institute for Regenerative Medicine (CIRM), the governing body charged with implementing Californias Proposition 71, a $3billion stem cell initiative and the state agency it created. Dr. Fontana was instrumentalin communicating this new science to the general public as well as editorial staff of themajor newspapers. She focused her early work on drug discovery for ALS and mostrecently in early detection of Alzheimers disease.

Alan L. Jakimo, JD, MBA - Alan joins the Board of Directors of the RegenerativeMedicine Foundation, which he continues to serve as Senior Policy Research Fellow, aposition he held at Genetics Policy Institute, a predecessor of RMF. Mr. Jakimo beganworking with GPI in the fields of policy research and patient advocacy in 2007. He is amember of the bar in New York, where he has focused on securities and technologytransactions since 1981. Alan is a member of the investment banking group at T.R.Winston & Company and teaches health law and drug development law at HofstraUniversity. In addition to his roles at RMF, he also serves as a director and advisor tononprofit organizations engaged in cancer R&D and life science.

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Ann Murphy, PhD Ann and her husband, Martin J. Murphy, co-founded AlphaMedPress in 1983 that launched STEM CELLS, the first journal devoted entirely to thesubject. With offices in Durham, NC, San Francisco, CA, and Belfast, NI, Ann publishesand is the executive editor of two other international peer-reviewed journals with globallyrecognized editorial boards dedicated to advancing research and education in theirfocused disciplines: The Oncologist and STEM CELLS Translational Medicine (the official journal partner of the Regenerative Medicine Foundation). In 2000, Ann co-founded the Society for Translational Oncology to fill the gap between discovery of newcancer treatments and their global translation into oncology practice. The Oncologist is its official journal.

About the Regenerative Medicine Foundation (RMF)

The nonprofit Regenerative Medicine Foundation fosters strategic collaborations toaccelerate the development of regenerative medicine to improve health and delivercures. RMF unites the worlds leading researchers, medical centers, universities, labs,businesses, funders, policymakers, experts in law, regulation and ethics, medicalphilanthropies, and patient organizations. We maintain a trusted network of leaders andpursue our mission by producing its flagship World Stem Cell Summit series ofconferences and public days, honoring leaders through the Stem Cell and RegenerativeMedicine Action Awards, supporting our official journal partner STEM CELLSTranslational Medicine (SCTM), promoting solution-focused policy initiatives bothnationally and internationally and creating STEM/STEAM educational projects. For moreinformation about RMF, please visit: http://www.regmedfoundation.org.

About the World Stem Cell Summit (WSCS)

Produced by the non-profit Regenerative Medicine Foundation (RMF), and in its 15 th year,the World Stem Cell Summit will take place January 21-24, 2020, in Miami, Florida. TheSummit is the most inclusive and expansive interdisciplinary, networking, and partneringmeeting in the stem cell science and regenerative medicine field. With the overarchingpurpose of fostering biomedical research, funding, and investments targeting cures, theSummit and co-located conferences serve a diverse ecosystem of stakeholders.Together with Phacilitate Leaders Asia and the Shanghai Institute of Medical Genetics,RMF produced the inaugural World Stem Cell Summit-CHINA in October 2019. Formore information about the upcoming 15 th World Stem Cell Summit in Miami, please visit:worldstemcellsummit.com.

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Joseph DawsonRegenerative Medicine Foundation561-906-4755joseph@regmedfountion.org

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REGENERATIVE MEDICINE FOUNDATIONS BOARD OF DIRECTORS EMBRACES NEW MEMBERS AND VISIONARY LEADERSHIP - Yahoo Finance

Funding to Support Ongoing Advancement of siFi2, Lead Candidate from Companys First-of-its-Kind Platform for Precisely Controlling Core Cell Migration Mechanisms

New York, NY, January 7, 2020 MicroCures, a biopharmaceutical company developing novel therapeutics that harness the bodys innate regenerative mechanisms to accelerate tissue repair, today announced that it has been awarded a Phase 2 Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). The two-year, $1.5 million award will support ongoing development of the companys lead product candidate, siFi2. siFi2, a small interfering RNA (siRNA) therapeutic that can be applied topically, is designed to enhance recovery after trauma. This Phase 2 grant continues the companys successful Phase 1 SBIR contract which demonstrated significantly improved repair of burn wounds following treatment with siFi2 in animal models.

MicroCures technology is based on foundational scientific research at Albert Einstein College of Medicine regarding the fundamental role that cell movement plays as a driver of the bodys innate capacity to repair tissue, nerves, and organs. The company has shown that complex and dynamic networks of microtubules within cells crucially control cell migration, and that this cell movement can be reliably modulated to achieve a range of therapeutic benefits. Based on these findings, the company has established a first-of-its-kind proprietary platform to create siRNA-based therapeutics capable of precisely controlling the speed and direction of cell movement by selectively silencing microtubule regulatory proteins (MRPs).

The company has developed a broad pipeline of therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. Unlike regenerative medicine approaches that rely upon engineered materials or systemic growth factor/stem cell therapeutics, MicroCures technology directs and enhances the bodys inherent healing processes through local, temporary modulation of cell motility. The companys lead drug candidate, siFi2, is a topical siRNA-based treatment designed to silence the activity of Fidgetin-Like 2 (FL2), a fundamental MRP, within an area of wounded tissue. In doing so, the therapy temporarily triggers accelerated movement of cells essential for repair into an injury area. Importantly, based on its topical administration, siFi2 can be applied early in the treatment process as a supplement to current standard of care.

We are grateful for NIHs continued support of our work through this multi-year Phase 2 SBIR grant. This non-dilutive financial support allows us to continue building a robust portfolio of preclinical data in animal models that demonstrate the therapeutic potential of siFi2 to significantly improve and accelerate healing of burn wounds, said David Sharp, Ph.D., co-founder and chief science officer of MicroCures. This funding will help advance our research as we work towards first-in-human clinical trial in 2020.

The initial Phase 1 SBIR grant from NIH funded preclinical research by MicroCures which demonstrated that treatment with siFi2 accelerated re-epithelization, improved collagen deposit and maturation, and improved quality of healing in a porcine full thickness burn model. Specific findings showed that following eight weeks of treatment, 39% of siFi2-treated wounds were closed as compared to only 11% for control subjects and 0% for placebo. Additionally, siFi2-treated subjects demonstrated a significantly improved rate of healing as measured by epithelial surface measurements as compared to placebo (p = 0.0106) and control (p = 0.0012).

About MicroCures

MicroCures develops biopharmaceuticals that harness innate cellular mechanisms within the body to accelerate and improve recovery after traumatic injury. MicroCures has developed a first-of-its-kind therapeutic platform that precisely controls the rate and direction of cell migration, offering the potential to deliver powerful therapeutic benefits for a variety of large and underserved medical applications.

MicroCures has developed a broad pipeline of novel therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. The companys lead therapeutic candidate, siFi2, targets excisional wound healing, a multi-billion dollar market inadequately served by current treatments. Additional applications for the companys cell migration accelerator technology include dermal burn repair, corneal burn repair, cavernous nerve regeneration, spinal cord regeneration, and cardiac tissue repair. Cell migration decelerator applications include combatting cancer metastases and fibrosis. The company protects its unique platform and proprietary therapeutic programs with a robust intellectual property portfolio including eight issued or allowed patents, as well as eight pending patent applications.

For more information please visit: http://www.microcures.com

Disclaimer: The SBIR Grant (2R44AR070696-02A1) is supported by the NIHs National Institute of Arthritis and Musculoskeletal and Skin Diseases. The content of this press release is solely the responsibility of MicroCures and does not necessarily represent the official views of the NIH.

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MicroCures Awarded $1.5M SBIR Grant To Support Development of Novel Therapeutic Platform for Accelerated Tissue Repair - BioSpace

BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated joint preservation and regenerative therapies company with products leveraging its proprietary hyaluronic acid (HA) technology platform, today announced it has signed agreements to acquire Parcus Medical, a leading, privately-held sports medicine company, and Arthrosurface, a leading, privately-held provider of joint surface and preservation solutions for active patients.

We are very excited about these acquisitions, which are consistent with Anikas commitment to expanding our portfolio into replacement and regenerative therapies for joint preservation and restoration, said Joseph Darling, President and Chief Executive Officer of Anika Therapeutics. These acquisitions will significantly enhance our commercial capabilities and infrastructure, diversify our revenue mix and expand our product portfolio and pipeline. Parcus Medical provides direct access to the high-growth ambulatory surgery center market, which will enable Anika to source new revenue streams, and Arthrosurface has an innovative product pipeline and an established direct hybrid sales model, which will accelerate our product platform strategy. Importantly, we are confident that these acquisitions, together with our existing product portfolio, will solidify Anikas position in the $7 billion sports and regenerative medicine market and strengthen our ability to deliver better patient experiences and drive sustained revenue growth that will ultimately enhance value for shareholders.

The company expects the Parcus Medical and Arthrosurface acquisitions to drive growth by:

Parcus Medical Acquisition

Parcus Medical has a diverse product family that helps facilitate surgical procedures on the shoulder, knee, hip and distal extremities. The acquisition of Parcus Medical will significantly expand Anikas offerings into the fast-growing ambulatory surgical center (ASC) market. The Parcus Medical executive team, led by President Mark Brunsvold, will join Anika and continue to lead the Parcus Medical business.

Together with Anika, we will continue our efforts to capitalize on the growing ASC market and reach more orthopedic surgeons with the products they rely on to care for patients, said Mark Brunsvold, President of Parcus Medical. We founded Parcus Medical with the belief that the future of healthcare would require a new balance between innovation, cost and product delivery. As we enter the next chapter for our company, we look forward to working closely with Joe and the Anika leadership team to continue to drive innovation across our portfolio.

Under the terms of the agreement, Anika will acquire all outstanding membership interests of Parcus Medical in exchange for an upfront payment of approximately $35 million in cash from the companys existing balance sheet, subject to customary closing adjustments. In addition, Parcus Medical unitholders will be eligible to receive an additional $60 million contingent upon the successful achievement of certain commercial milestones. Parcus Medical is expected to generate approximately $12 million to $13 million of revenue for the full year of 2019, an increase of approximately 15 percent compared to the prior year.

Arthrosurface Acquisition

Arthrosurfaces product portfolio includes more than 150 different surface implant curvatures for the knee, shoulder, hip, ankle, wrist and toe that are designed to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. The Arthrosurface executive team, led by President and Chief Executive Officer Steven Ek, will join Anika and continue to lead the Arthrosurface business innovation.

Joining Anika will provide our team a larger platform and greater resources to bring innovative solutions to market and support healthcare professionals to provide better care to patients seeking treatments that will help them stay active and pain-free, said Steven Ek, President and Chief Executive Officer of Arthrosurface. Since our founding, we have treated more than 100,000 patients and we now have over 5,000 surgeons using our products across more than 25 countries. We are confident that this transaction will position our pipeline for success and help us extend our leadership in sports medicine.

Under the terms of the agreement, Anika will acquire all outstanding shares of Arthrosurface in exchange for an upfront payment of approximately $60 million in cash from the companys existing balance sheet, subject to customary closing adjustments. In addition, Arthrosurface shareholders will be eligible to receive an additional $40 million contingent upon successful achievement of certain regulatory and commercial milestones. Arthrosurface is expected to generate approximately $28 million to $30 million of revenue for the full year of 2019, an increase of approximately 10 percent compared to the prior year.

Additional Details

The transactions are subject to approval by the unitholders of Parcus Medical and the shareholders of Arthrosurface, and Anika anticipates both acquisitions will close in the first quarter of 2020, subject to customary closing conditions.

SVB Leerink LLC acted as exclusive financial advisor to Anika and Sullivan & Cromwell LLP acted as Anikas legal counsel in connection with the transactions.

Conference Call Information

Anikas management will hold a conference call and webcast to discuss the acquisitions on Wednesday, January 8 at 8:30 a.m ET to allow Anikas President and CEO to recover from a brief bout with laryngitis. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the "Investor Relations" section of Anikas website, http://www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anikas website approximately two hours after the completion of the event.

About Parcus Medical

Parcus Medical, LLC. is focused on providing implant and instrumentation solutions used by surgeons to repair and reconstruct damaged ligaments and tendons due to sports injuries, trauma and disease. Founded in 2007, Parcus has created more than 400 products, manufactured in its Sarasota, Florida facilities, that have helped surgeons restore the function, mobility and health of the patients they serve, in countries around the world. To see Parcus Medicals ever-expanding list of innovative products, please visit http://www.parcusmedical.com.

About Arthrosurface

Arthrosurface, Inc. is a global leader in joint preservation technology, manufacturing less invasive joint replacements that are clinically proven to help patients stay active by increasing range of motion and reducing pain. The companys product portfolio features more than 150 different surface implant curvatures for the knee, shoulder, hip, ankle, wrist and toe that are designed to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. More than 100,000 patients have been treated with Arthrosurface implants since the company was founded in 2002. Arthrosurface markets and distributes its products in the United States and around the world, with more than 5,000 surgeons currently using Arthrosurface products in more than 25 countries. For more information about Arthrosurface, please visit http://www.arthrosurface.com.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated joint preservation and regenerative therapies company based in Bedford, Mass. Anika is committed to delivering therapies to improve the lives of patients across a continuum of care from osteoarthritis pain management to joint preservation and restoration. The company has more than two decades of global expertise commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology platform. For more information about Anika, please visit http://www.anikatherapeutics.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, concerning, but not limited to, the acquisition of ArthroSurface and Parcus Medical and the effects of the two acquisitions. The Securities and Exchange Commission ("SEC") encourages companies to disclose forward-looking statements so that investors can better understand a companys future prospects and make informed investment decisions. Forward-looking statements are subject to risks and uncertainties, many of which are outside our control, which could cause actual results to differ materially from these statements. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements can be identified by such words as "will," "likely," "may," "believe," "expect," "anticipate," "intend," "seek," "designed," "develop," "would," "future," "can," "could," and other expressions that are predictions of or indicate future events and trends and that do not relate to historical matters. All statements other than statements of historical facts included in this press release regarding our strategies, prospects, financial condition, operations, costs, plans, and objectives are forward-looking statements. Factors that could cause or contribute to changes in such forward-looking statements include, but are not limited to (i) failure to realize the anticipated benefits of the acquisitions, (ii) unexpected expenditures or assumed liabilities that may be incurred as a result of the acquisitions, (iii) loss of key employees or customers following the acquisitions, (iv) unanticipated difficulties in conforming business practices, including accounting policies, procedures, internal controls, and financial records of ArthroSurface and Parcus Medical with the Company, (v) inability to accurately forecast the performance of ArthroSurface and Parcus Medical resulting in unforeseen adverse effects on the Companys operating results, (vi) failure to satisfy the conditions to the completion of the acquisitions on the anticipated schedule, or at all, and (vii) synergies between ArthroSurface or Parcus Medical and the Company being estimates which may be materially different from actual results.

Please refer to the factors set forth under the heading "Risk Factors" in the Companys Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC, as may be amended or supplemented in subsequently filed Quarterly Reports on Form 10-Q for important factors that we believe could cause actual results to differ materially from those in our forward-looking statements. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise.

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Anika Therapeutics to Acquire Parcus Medical and Arthrosurface - Business Wire

The Salk Institutes courtyard after a rainstorm.

Salk Institute professors and La Jolla residents Rusty Gage, Ron Evans, and Juan Carlos Izpisua Belmonte were on the list of the Highly Cited Researchers of 2019. With the help of the global citation database, Web of Science Group, and Clarivate Analytics, this annual list recognizes the worlds most influential science and social science researchers whose papers rank in the top 1% by citations in their field of study.

Rusty Gage, the Salk Institutes president, professor in the Laboratory of Genetics, and Vi and John Adler Chair on Age-Related Neurodegenerative Disease, is among those recognized. Gage, who has been at Salk since 1995, studies the adaptability of mammals to their environment.

It is very meaningful to me to be listed alongside so many colleagues whose work I respect and admire, says Gage. We are all scientists because we love the process by which science seeks to understand the world. We are fortunate not only to do something we love, but also to be rewarded for it.

Ron Evans, professor and director of Salks Gene Expression Laboratory and the March of Dimes Chair in Molecular and Developmental Biology was also recognized. He has been with the Salk Institute just over 40 years, and his lab studies the role of hormones and nuclear hormone receptors, one of his labs discoveries, which are a family of molecules that respond to hormones.

Its an honor to be on a list that includes so many scientific luminaries, says Evans. At Salk, we are seekers tackling some of the toughest problems in biology and medicine. We get to turn dreams into reality.

The third La Jolla resident and Salk Institute professor to be recognized is professor in Salks Gene Expression Laboratory and the Roger Guillemin Chair, Juan Carlos Izpisua Belmonte. His lab studies the origins of cells, tissues, and organs by conducting experiments with stem cells. Izpisua Belmonte has been at Salk since 1993.

I feel very honored to be named to this list with so many of my Salk colleagues and many scientists who are working hard for the better of humanity, says Izpisua Belmonte.

In 2020, all three researchers hope to make great advances in their labs. Izpisua Belmonte is looking forward to making new discoveries in the areas of mammalian development and regenerative medicine and aging. Evanss lab hopes to open new frontiers in pancreatic cancer, inflammatory bowel disease, and Type 1 diabetes. As Salks president, Gage is excited for Salk scientists to continue collaborating to find ways to tackle an array of health and environmental challenges.

Additionally, 2020 marks the Salk Institute's 60th anniversary. We look forward to celebrating this landmark with the San Diego community, such as through events like our Explore Salk open house coming up in the spring, says Gage.

Congratulations to the La Jolla residents and Salk Institute professors recognized on the list of Highly Cited Researchers of 2019. To learn more about the Salk Institute, visit salk.edu.

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Salk Institute professors named highly cited researchers of 2019 - Salk Institute professors and La Jolla residents Rusty Gage Ron Evans and Juan...

CES 2020 already has the world buzzing about what is coming on the tech front in 2020. From robo-pets to rotating TVs, the next 12 months will usher in a new wave of innovative products, services, and concepts.

The global startup ecosystem continues to grow at a rapid clip. VC funding reached an all-time high in India last year, e-scooter companies eclipsed billion-dollar valuations, and major corporations continued to diversify with large-scale investments in early-stage concepts.

Through all the noise, several startups have burst onto the scene and are tackling big challenges in new ways. If they succeed, our lives and world could change in significant ways.

Every year, U.S. retailers throw out $18 billion worth of spoiled food. The San Francisco-based startup, Afresh, aims to change that. The company developed software that uses algorithms and AI to help stores eliminate waste and optimize their perishable inventories.

Entering its fifth year of operation, Afresh now has multiple partnerships with high-profile grocery chains and is working on closing additional deals in the coming year. Those who work with Afresh have already reported that they have been able to reduce food waste by 50 percent.

The mortgage application process is still a tedious and outdated experience. New York City-based Better.com is breathing fresh life into the space by putting the process online and removing fees or commissions. Pre-approval on Better.com is automated and only takes minutes instead of weeks.

After a $160 million funding round in August, the startup is prepared to lend even more in 2020. In 2019, Better.com lent over $4 billion to homebuyers. The company currently operates in 44 states and expects to be in all 50 by March.

Movandi is an Irvine-based startup that wants to make 5G more accessible for those outside of dense urban areas. The company has developed technology that extends the reach of 5G spectrum bands and enables signals to bend around obstacles that would otherwise hinder services.

Movandi has raised $30 million in funding to date and is attempting to partner with the leading wireless providers in the country. As 5G ramps up, Movandis opportunity grows in parallel.

New York City-based Petal is attempting to transform credit card approvals for the benefit of those with limited credit histories. The startup determines eligibility using non-credit score factors, such as income and bank statements.

Petals services target young people who may not have established solid lines of credit. Coming off of a $30 million VC funding round and $300 million in debt financing, the company is ready for a huge 2020.

Shape Therapeutics is developing technology that will enable scientists to modify human RNA to address certain diseases and mutations. The Seattle-based company was founded in 2018 and has since raised over $35 million to expand and open a new location in Cambridge.

The UC-San Diego bioengineering professor, Prashant Mali, is behind the startups groundbreaking work. Malis research lab integrates expertise in several fields, including regenerative medicine, synthetic biology, and materials engineering. Experts report that Shape Therapeutics has evolved beyond the highly touted Crispr-Cas9 process.

Continue reading here:
5 disruptive tech startups to watch in 2020 - The Burn-In

It was a great year for ASX healthcare shares in 2019, with the S&P/ASX Healthcare Index increasing by 41%.

These 3 ASX healthcare shares experienced even greater gains in 2019, but can they continue to outperform in 2020?

Avita Medical is a regenerative medicine company specialising in spray-on skin therapy for dermal applications. Avita Medicals shares increased 700% over 2019, and are currently trading at 60 cents.

Sales of Avitas lead product, the RECELL System, increased 60% in the September 2019 quarter.The RECELL System is currently used to treat burn wounds but is also being assessed for use in treating vitiligo, traumatic wounds, scar reconstruction, and for aesthetic indications. In December, Avita reported the FDA had approved a study investigating the use of the RECELL System in the treatment of vitiligo. More than 1,000 patients have already been treated globally for vitiligo and reported re-pigmentation.

More than 50% of US burn surgeons and centres are now trained on the RECELL System and 56 of 132 US burns centres have placed orders for it. The company reported total revenue in the September quarter of $7,900,000, an increase of 165% over September 2018 revenues of $2,972,000.

In November, Avita raised $120 million in equity capital via a placement of 203,389,831 shares at 59 cents per share. Funds are earmarked for the pipeline development of new indications, including optimising support for clinical trials and development projects, as well as the companys continued US growth. In FY20, Avita Medical plans to commence trials establishing the safety and efficacy of RECELL in paediatric treatment, and for soft tissue and traumatic wounds. Japanese regulatory approval for the use of the RECELL System is also expected in 2020.

An announcement regarding a collaboration using the system for rejuvenation is expected in 1H20. Capturing just 5% of the skin rejuvenation market could represent a >$500 million opportunity.

Paradigm is an Australian biopharmaceutical company focused on repurposing the drug pentosan polysulphate sodium (PPS) for the treatment of osteoarthritis. Paradigm shares increased 195% in 2019 and are currently trading at $3.02.

PPS is an FDA approved drug with a long track record of treating inflammation over 60 years.Paradigm has developed an injectable form of PPS, called Zilosul, intended to treat osteoarthritis. Osteoarthritis is the most common joint disorder in the United States (US) and is likely to increase due to the ageing population and obesity epidemic. The company reports that there are currently more than 100 million osteoarthritis sufferers in the US, Europe, and Japan.

The Phase 2b trial successfully met primary, secondary, and exploratory endpoints. After 53 days, nearly half of patients given Zilosul reported >50% reduction in pain compared to around 20% of patients given a placebo. Competing treatments have not demonstrated the same combination of safety, efficacy, and regression of disease.

Paradigm met with the Australian Therapeutic Goods Administration in November to present its case for provisional approval of Zilosul as a treatment for knee osteoarthritis. If provisional approval is successful Paradigm could be generating revenue in Australia as early as the third quarter of 2020. With 3 million sufferers, the revenue potential in Australia at 20% market share is as much as $1.5 billion per annum.

In the first quarter of 2020, the company will also be meeting with the US Food and Drug Administration (FDA) and the European Medicine Agency to determine the clinical trial design that will support regulatory approval in both jurisdictions. Paradigm expects the Phase 3 trial to begin in mid 2020. The revenue potential in the US at 10% market share is as much as $9 billion per annum.

Zilosul has been granted FDA approval under the Expanded Access Program to treat 10 patients, all ex-NFL players suffering osteoarthritis. The players were treated at the end of 2019 and results from their treatment are expected in mid 2020.

Polynovo is a medical device company which manufactures an implantable dressing (Novosorb BTM) that can be integrated into the body as it heals. Polynovo shares increased more than 200% during 2019 and are currently trading at $1.91.

Story continues

PolyNovo recently announced that it has recorded its first month of $2 million in revenue from the Novosorb BTM product in December. The first $1 million month occurred in May. CEO Paul Brennan said, We are pleased with the sales trend, however as a word of caution sales will continue to be lumpy as new sales staff are added and new territories opened up and because of natural disasters such as fires and volcanoes.

The Novosorb BTM product had been granted a certificate of conformance (CE mark) approval in December for sale throughout the UK, Ireland, and the European Union. The company reports it already has strong brand recognition and awareness of its clinical success in these markets via international conferences, publications and peer interactions. A further announcement regarding prospects in this region is expected shortly.

Following the White Island volcano tragedy the company announced it had supplied the Novosorb BTM product to 3 hospitals in New Zealand and 2 in Australia. The product, it said, mitigates some of the serious challenges involved in treating mass trauma and burns.

Sales of Novosorb BTM increased from $1.7 million in FY18 to $9.3 million by FY19. Guidance for FY20 has been in the region of $12 million, however the company is seeing growth in all markets. Growth in the US business is very strong and the company reports that Novosorb BTM product is changing clinical practice in many areas.

These ASX healthcare shares outperformed the index in 2019. Whether they can do so again in 2020 remains to be seen. For Avita Medical and Paradigm much will depend on the results of their clinical trials and regulatory approvals. For Polynovo, results will largely depend on sales of Novosorb BTM, which appear promising so far.

The post Can these 3 ASX healthcare shares outperform the index in 2020? appeared first on Motley Fool Australia.

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Can these 3 ASX healthcare shares outperform the index in 2020? - Yahoo Finance

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Global Regenerative Medicine Market 2019: Expected Development, Share, Demand And Study Of Key Players- Research Predictions 2024 - The Picayune...

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