Medtech

The Power of Clinical Data: Why Strategic PMCF Studies Matter, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Mittwoch, Mai 1, 2024
Medtech, Research, MDR, Medical device, Behavior, Collection, PMS, Regulatory affairs, Safety

TORONTO, May 1, 2024 /PRNewswire-PRWeb/ -- Post-market clinical follow-up (PMCF) studies are necessary for continuously monitoring the clinical benefits, performance and safety of a medical device once it is released on the market. As part of a broader post-market surveillance (PMS) strategy, these studies are crucial for assessing the long-term behavior of the device and ensuring that the risk–benefit profile remains favorable when the device is used as intended.

Key Points: 
  • In this webinar, learn about the regulatory framework for post-market clinical follow-up (PMCF).
  • Attendees will gain insights into planning a PMCF strategy and designing a PMCF investigation.
  • TORONTO, May 1, 2024 /PRNewswire-PRWeb/ -- Post-market clinical follow-up (PMCF) studies are necessary for continuously monitoring the clinical benefits, performance and safety of a medical device once it is released on the market.
  • Register for this webinar to explore key regulatory and clinical considerations for PCMF investigations under EU MDR.

Arcuro Medical Appoints Jamal Rushdy CEO

Retrieved on: 
Mittwoch, Mai 1, 2024
Medtech, SGX, Surgeon, Elective surgery, CDMO, Patient, Sports medicine, Quality of life, Growth

MINNEAPOLIS and MISGAV, Israel, May 1, 2024 /PRNewswire/ -- Arcuro Medical Ltd. ( www.arcuromedical.com ), a portfolio company of The Trendlines Group (SGX: 42T) (OTCQX: TRNLY), today announced the appointment of MedTech industry veteran Jamal Rushdy as Chief Executive Officer.

Key Points: 
  • MINNEAPOLIS and MISGAV, Israel, May 1, 2024 /PRNewswire/ -- Arcuro Medical Ltd. ( www.arcuromedical.com ), a portfolio company of The Trendlines Group (SGX: 42T) (OTCQX: TRNLY), today announced the appointment of MedTech industry veteran Jamal Rushdy as Chief Executive Officer.
  • He most recently served as President and CEO of Collagen Solutions, a successful, high-growth, biomaterials and CDMO company.
  • "The team at Arcuro Medical has made great progress in its mission to assist surgeons in improving their patients' quality of life," said Jamal Rushdy, CEO of Arcuro Medical.
  • Rushdy succeeds Lee Ranon, Arcuro Medical's co-founder, who will continue to serve as the company's Chief Operating Officer – Israel, overseeing R&D, Regulatory and Quality, and Israel Operations.

GT Medical Technologies, Inc. and Theragenics Corporation Forge Distribution Partnership for Cesium-131

Retrieved on: 
Mittwoch, Mai 1, 2024
Medtech, FDA, Radiation, Brachytherapy, Seed, Partnership, Isotopes of caesium, Brain, Prostate cancer, Patient, Neoplasm, Medical imaging

TEMPE, Ariz., May 1, 2024 /PRNewswire/ -- GT Medical Technologies, Inc. (GT MedTech), a medical device company with the mission of improving the lives of patients with brain tumors, today announced it has entered into a strategic distribution partnership with Theragenics Corporation® (Theragenics), a global leader in minimally invasive brachytherapy. The partnership aims to expand physician access to Cesium-131 seeds, offering greater flexibility to support their brachytherapy procedural needs.

Key Points: 
  • TEMPE, Ariz., May 1, 2024 /PRNewswire/ -- GT Medical Technologies, Inc. (GT MedTech), a medical device company with the mission of improving the lives of patients with brain tumors, today announced it has entered into a strategic distribution partnership with Theragenics Corporation® (Theragenics), a global leader in minimally invasive brachytherapy.
  • The partnership aims to expand physician access to Cesium-131 seeds, offering greater flexibility to support their brachytherapy procedural needs.
  • Through the partnership, Theragenics will become the exclusive distributor of Cesium-131 brachytherapy seeds and carriers used for a variety of non-brain cancer related treatments including prostate cancer.
  • Michael Krachon, President of Theragenics Interventional, added, "This partnership reinforces Theragenics' unwavering commitment to brachytherapy.

Integrity Orthopaedics Announces Closure of Series B Financing

Retrieved on: 
Dienstag, April 30, 2024
FDA, IP, Sports medicine, General counsel, Surgeon, Medtech, Shoulder, Entrepreneurship, Environment, Atrium Health, Patient, Physician, Series, Immobilization, Young, 3D printing

MINNEAPOLIS, April 30, 2024 /PRNewswire/ -- Integrity Orthopaedics, Inc., a company pioneering next generation solutions for soft tissue repair, has successfully closed on a Series B financing of $20.6 million.

Key Points: 
  • MINNEAPOLIS, April 30, 2024 /PRNewswire/ -- Integrity Orthopaedics, Inc., a company pioneering next generation solutions for soft tissue repair, has successfully closed on a Series B financing of $20.6 million.
  • "We are pleased to co-lead the Series B financing," said Tom Schnettler, Managing Director, Piper Sandler Merchant Banking.
  • The Integrity Orthopaedics system is designed to address the biggest unmet need in rotator cuff repairs, reducing the occurrence of cuff re-tears following surgical repair.
  • The Integrity Orthopaedics system was FDA cleared in early 2023 and initially utilized by a small group of surgeons in a limited launch.

EQS-News: MAX Automation SE concludes agreement on sale of MA micro Group

Retrieved on: 
Freitag, Mai 3, 2024
Medtech, Sale, Gesellschaft mit beschränkter Haftung, Investment, Automation, EUR, Growth, Frankfurt Stock Exchange, Supervisory board, Acquisition

The purchase price for the MA micro Group, consisting of MA micro automation GmbH and its subsidiaries MA Life Science GmbH, Micro Automation LLC, and Micro Automation LLP, amounts to a range of approximately EUR 71.5 million to EUR 76.5 million, subject to 2024 performance of the MA micro Group.

Key Points: 
  • The purchase price for the MA micro Group, consisting of MA micro automation GmbH and its subsidiaries MA Life Science GmbH, Micro Automation LLC, and Micro Automation LLP, amounts to a range of approximately EUR 71.5 million to EUR 76.5 million, subject to 2024 performance of the MA micro Group.
  • Guido Mundt, Chairman of the Supervisory Board of MAX Automation SE: “MA micro Group is very well positioned both operationally and financially and has become a leading technology provider with its focus on the MedTech market.
  • The MA micro Group is therefore a good example of the implementation of our strategy to enhance the development and potential of our investments.
  • Houlihan Lokey Germany is acting as transaction advisor and Hengeler Mueller as legal advisor to MAX Automation.

Affluent Medical : 2023 financial results and update on clinical activities under development.

Retrieved on: 
Freitag, Mai 3, 2024
Medtech, FDA, Risk, De novo, Death, Mitral regurgitation, Doctor of Philosophy, Wound healing, Mitral valve annuloplasty, Boston Scientific, Ticker, Wealth, Urinary incontinence, Woman, Christophe, Food, Neurostimulation, Myocardial infarction, Aix-en-Provence, DSM-IV codes, LCEA, Mitral valve, TAVI, Minerva, Certification, Heart, Quality assurance, System, Anatomy, Exercise, NYHA, Dry, Marketing, Clinical trial, American College, Development director, MD, Endocarditis, Medtronic, Patient, Tricuspid valve, Acquisition, Medical device

Affluent Medical : 2023 financial results and update on clinical activities under development.

Key Points: 
  • Affluent Medical : 2023 financial results and update on clinical activities under development.
  • Affluent Medical estimates that KaliosTM would avoid repeat surgery for 30-40% of patients within five years of their operation.
  • In September 2023, the Company presented interim data on 20 patients treated in five clinical centers in Europe after one year of implantation.
  • In July 2023, Affluent Medical announced the appointments of Christophe de Vregille as Chief Financial Officer and Benjamin Renault as Development Director.

Mikron shareholders approve all proposals of the Board of Directors

Retrieved on: 
Freitag, Mai 3, 2024
Annual, Mikron Group, Medtech, CHF, SIX Swiss Exchange

The members of the Board of Directors Paul Zumbühl, Andreas Casutt, Hans-Michael Hauser, Alexandra Bendler and Hans-Christian Schneider were re-elected for a one-year term of office.

Key Points: 
  • The members of the Board of Directors Paul Zumbühl, Andreas Casutt, Hans-Michael Hauser, Alexandra Bendler and Hans-Christian Schneider were re-elected for a one-year term of office.
  • The Mikron Group develops, produces and markets very precise, productive and adaptable automation solutions, machining systems and cutting tools.
  • The two business segments Mikron Automation and Mikron Machining Solutions are based in Switzerland (Boudry and Agno).
  • Mikron Switzerland AG, Philippe Wirth, CFO Mikron Group, phone +41 91 610 63 54, [email protected]

BioStem Technologies Inc. Completes Two-Year Audit, Prepares for Uplisting to Senior Exchange

Retrieved on: 
Mittwoch, April 24, 2024
Medtech, CMS, OTC, Security (finance), DFU, Defense, Regenerative medicine, Ulcer, Clinical trial, Growth, Pharmaceutical industry

This completion is a significant step in the company’s strategy to uplist to a senior stock exchange.

Key Points: 
  • This completion is a significant step in the company’s strategy to uplist to a senior stock exchange.
  • The successful audit is a strategic move toward uplisting to a senior exchange, which the company anticipates will help to further validate its market position, attract a broader investor base, and enhance shareholder value.
  • Jason Matuszewski, CEO of BioStem Technologies, stated, "Completing this rigorous two-year audit underscores our dedication to transparency and regulatory compliance.
  • 2023 was a pivotal year for BioStem, marked by robust revenue growth, particularly in Q4, establishing a solid foundation for the company's future expansion.

Pattern to Present in London, UK at the LSX World Congress

Retrieved on: 
Mittwoch, April 17, 2024
Congress, Investment, AI, Research, Medtech, Business, Pattern, LSX, Cancer, PDE, Management

REDMOND, Wash., April 16, 2024 (GLOBE NEWSWIRE) -- Pattern Computer®, Inc. (“Pattern” or “the Company”) today announced that Mark R. Anderson, Chairman and CEO, will be presenting at the LSX World Congress which will take place in London, UK on April 29-30, 2024, at the Business Design Center.

Key Points: 
  • REDMOND, Wash., April 16, 2024 (GLOBE NEWSWIRE) -- Pattern Computer®, Inc. (“Pattern” or “the Company”) today announced that Mark R. Anderson, Chairman and CEO, will be presenting at the LSX World Congress which will take place in London, UK on April 29-30, 2024, at the Business Design Center.
  • LSX World Congress is the leading partnering, strategy, and investment event in Europe, with a strong focus on one-to-one partnering.
  • “Pattern is a pioneer in finding novel patterns in complex data that cannot be discovered using other techniques or tools,” commented Mr. Anderson.
  • Pattern is optimally positioned to leverage the expertise of our Pattern Discovery Engine™ (PDE) into the next worlds of trustworthy, transparent computing.

Outcome Capital Expands Its Medical Device and Life Science Services Practices with the Addition of Industry Veteran Peter F. Meyer, Ph.D.

Retrieved on: 
Donnerstag, Mai 2, 2024
Professional Services, Health, Medical Devices, Other Health, Other Science, Finance, Science, Doctor of Philosophy, Corporation, Medtech, Physics, Investment, Mechanical engineering, Capital, Boston University, Biomedical engineering, Business development, Partnership, Columbia University, Providence College, Medtronic, Biomedicine, Acquisition

Dr. Meyer will expand the firm’s Medical Device and Life Sciences Services practices within Outcome’s unique strategy-driven platform, providing M&A, capital raising, and advisory services to his clients.

Key Points: 
  • Dr. Meyer will expand the firm’s Medical Device and Life Sciences Services practices within Outcome’s unique strategy-driven platform, providing M&A, capital raising, and advisory services to his clients.
  • An industry veteran with over 25 years of strategic investment and commercial execution experience in MedTech and the Life Sciences, Dr. Meyer brings a professional focus on leveraging industry best-practices for strategy development, market entry and growth acceleration.
  • Unique among investment banking firms, Outcome’s strategic approach to value enhancement relies on significant corporate and operational experience.
  • He is a certified Design for Six Sigma Black Belt and holds over 30 patents in medical technology.