Deal to acquire outstanding shares of TEI Medical, TEI Biosciences closed by Integra | Seed funding round pulls in $2M for S.C.-based firm | Dx firm to be acquired by Roche in up-to-$425M deal
August 14, 2015
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Deal to acquire outstanding shares of TEI Medical, TEI Biosciences closed by Integra
Integra LifeSciences has completed the purchase of the outstanding shares of TEI Medical and TEI Biosciences. The deal will expand Integra's regenerative wound care and reconstructive products portfolio and gives Integra 125 managers and sales reps in the U.S. (Boston) (8/13)
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Business & Market Trends
Seed funding round pulls in $2M for S.C.-based firm
A round of seed financing has brought in $2 million for early-stage medtech firm International Biomedical Devices. The Mount Pleasant, S.C.-based firm will use the proceeds to back preclinical trials and product development. The company's lead product is the ApertureRx, a precision capsulotomy technology intended to deliver precise incisions during cataract procedures. The Post and Courier (Charleston, S.C.) (free registration) (8/13), (Boston) (8/13)
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Dx firm to be acquired by Roche in up-to-$425M deal
GeneWEAVE BioSciences, a diagnostics firm, will be purchased by Roche in a deal worth up to $425 million. The acquisition will boost Roche's efforts against drug-resistant bacteria, giving it access to GeneWEAVE's Smarticles platform, which can quickly identify multidrug-resistant bacteria from clinical samples. Under the terms of the agreement, GeneWEAVE is entitled to receive an upfront payment of $190 million and up to $235 million in potential milestone payments. Reuters (8/13), PharmaTimes (U.K.) (8/13)
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GEC test growth drives Q2 revenue growth for Veracyte
Veracyte generated $11.9 million in revenue in the quarter ending June 30, up from $8.7 million in the same period in 2014. The second-quarter growth was attributed to higher sales of its Afirma gene expression classifier tests. GenomeWeb Daily News (free registration) (8/13)
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Q2 revenue increases for Transgenomic
Omaha, Neb.-based Transgenomic generated $7 million in revenue in the quarter ending June 30, up from $6.8 million in the same period last year. The second-quarter growth was driven by the firm's higher laboratory services revenue, which reflects greater sales of its patient tests. GenomeWeb Daily News (free registration) (8/13)
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Second Sight names former Volcano exec CEO, president
Will McGuire was tapped to serve as president and CEO at Second Sight Medical Products starting Aug. 18. McGuire, who previously served as Volcano's president of Americas commercial, succeeds Dr. Robert Greenberg, who will become chairman of Second Sight's board. (Boston) (8/13)
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Science & Health
Report: Global market for orthopedic products could near $47B by 2020
A Research and Markets report predicts the worldwide orthopedic products market will hit nearly $47 billion by 2020. The growing geriatric population as well as the rising rate of obesity, osteoporosis, osteoarthritis and sports injuries will drive the market, the report said. (8/13)
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Emerging Technologies
Joint fusion system from Zyga cleared by FDA
The Simmetry system, a sacroiliac joint fusion device developed by Zyga Technology for single or double incisions, has obtained 510(k) clearance from the FDA. The Minnetonka, Minn.-based firm manufactures surgical devices designed to address lumbar spine disorders. (Boston) (8/13)
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Government & Regulatory
AdvaMed: Unique device identifiers would boost postmarket medtech surveillance
While critics and new research raise safety concerns over the proposed expedited pathway for breakthrough treatments called for in the 21st Century Cures bill, AdvaMed contends that the use of unique device identifiers could make the postmarket surveillance of medical devices stronger. The group said although rigorous postmarket review is necessary, it must be balanced against patients' needs because "requirements that are too burdensome will discourage development and dissemination of new treatments and cures." The Examiner (Washington, D.C.) (8/13)
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FDA clears blood pregnancy test from NOWDiagnostics
The ADEXUSDx, a blood test designed by NOWDiagnostics to detect pregnancies in 10 minutes, has received 510(k) clearance from the FDA. The Springdale, Ark., firm said the product delivers faster results than urine-based tests. It is now available in Europe and the U.S. FDAnews (8/14)
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Medical Technology Learning Institute
Japan's Pharmaceutical and Medical Device Law: One Year Later Workshop
Oct. 29-30 | Washington, D.C.
You'll gain knowledge about Japan's revised Pharmaceutical and Medical Devices Law and its impact from key Japanese officials. Case studies and examples from the first year of implementation will also be discussed. Regulatory affairs and R&D officers at the operational and management levels who support product registration in Japan, as well as quality affairs and operation officers who are involved in QMS audits at a source plant, will benefit from this workshop. Learn more.
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Recalls From A to Z: Regulations, Decisions, Procedures & Best Practices
Oct. 27-28 | Washington, D.C.
FDA staff and industry leaders will help you establish a clear understanding of how the regulatory affairs function is pivotal to every recall and every team decision. You'll partake in detailed discussions and strategies for communicating with the FDA, and learn the points to consider when writing public recall notifications. Learn more.
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