Beta Bionics, Inc.

Medtronic has earned FDA approval that will allow it to broaden the scope of its MiniMed 780G system portfolio. FDA has cleared Medtronic’s SmartGuard algorithm as an interoperable automated glycemic controller, allowing integration with the Instinct sensor, made by Abbott, for type 1 diabetes. The MiniMed 780G system has also been approved for use in adults over 18 with insulin-requiring type 2 diabetes. These clearances complete Medtronic’s FDA pre-market approval pathway for the Instinct sensor integration with MiniMed 780G system for people living with type 1 diabetes. Medtronic previously earned clearance for the MiniMed 780G insulin pump as an alternate controller enabled pump. The Instinct sensor was designed by Abbott for MiniMed automated insulin delivery and Smart MDI systems. It is the world's smallest, thinnest, and most discreet integrated CGM, according to the company, and offers a wear time of up to 15 days. "We're working together to do what's best for people living with diabetes," Chris Scoggins, Executive Vice President of Abbott's diabetes care business, said in a prepared statement. "Abbott's biowearable technology has long set the standard for accurate, accessible, easy-to-use continuous glucose monitoring. Connecting it with the MiniMed™ 780G system aims to reduce the mental load of daily management, making it easier for people to live with diabetes." Over the next several weeks, Medtronic and Abbott will work together on required compliance documentation, and enable sensor integration and marketing to complete regulatory approvals. Once approvals are complete, patients will be able to order the Instinct sensor with the MiniMed 780G system. Pre-orders for Simplera Sync sensor will also begin later this month. FDA’s approval of the MiniMed 780G system for people with insulin-requiring type 2 diabetes, makes it the first and only automated insulin delivery system with Meal Detection technology available to patients living with type 2. "This approval extends the benefits of automated insulin delivery to people with type 2 diabetes," Natalie Bellini, an Endocrine Nurse Practitioner and Program Director for Diabetes Technology at University Hospitals in Cleveland, Ohio, said in a prepared statement. "It also aligns with the ADA Standards of Care, which now formally endorse AID systems for individuals with type 2 diabetes on intensive insulin therapy." According to clinical studies, the MiniMed 780G system can improve glycemic outcomes and reduce treatment burden for patients living with type 2, easing the burden of frequent injections, meal planning, and glucose monitoring. The MiniMed 780G system is currently available for type 2 diabetes with the Guardian 4 sensor and will be available with Simplera Sync sensor when pre-orders begin later this month. Medtronic is also seeking clearance for an interoperable pump indicated for type 2 diabetes, which would enable future integration with the Instinct sensor. Medtronic Diabetes has been a pioneer in the space for the last 40 years, designing nextgen CGMs, smart dosage systems, and more, and this is not the company’s first time teaming up with Abbott in the space. In August 2024, the two companies announced a collaboration that would have Abbott design a continuous glucose monitor system for Medtronic. The two worked on an integrated CGM based on Abbott’s FreeStyle Libre technology that connects with Medtronic’s automated insulin delivery and smart insulin pen systems. The integration of Abbott's CGM sensor with Medtronic's AID algorithms aimed to enable automatic adjustments of insulin to keep glucose in range. Abbott has continued to become a majorly sought-after partner in the space, teaming up with other rivals for glucose and ketone sensing technology. The company announced collaborations with Beta Bionics, Tandem, and Ypsomed’s partner CamDiab for 2025. In addition, both Abbott and Medtronic have held weight on their own in the diabetes and CGM space. In April, Medtronic reported FDA approval of the Simplera Sync sensor for use with the MiniMed 780G system, a disposable, all-in-one sensor that requires no fingersticks with SmartGuard or overtape. In January, Abbott reported triple growth drivers in diabetes tech, as its CGM platform continued to shine bright , with theLibre CGM contributing $1.8 billion in sales in the fourth quarter of 2024. In its Q1 FY2026 earnings call, Medtronic teased the Abbott partnership. “In diabetes, we expect performance to accelerate as we launch two new sensors, Simplera Sync this fall and the Abbott based sensor, which we're calling Instinct, in the coming months. Simplera is half the size of our current sensor,” Geoff Martha, Medtronic’s CEO, said on the call. “It's disposable, and it's much easier to put on with with no over tape. And with Instinct, our customers will get access to Abbott's most advanced CGM platform. And when you combine these these improved sensors with our MiniMed seven eighty g and its exclusive meal detection technology, we expect to see a positive inflection in our installed base and revenue growth. As for the separation of our diabetes business, MiniMed, we're calling it, is proceeding according to plan. MiniMed is entering a strong innovation cycle in its own right.”

Shoulder Innovations also provides AI-powered surgical planning software, with the FDA-cleared ProVoyance, which translates CT images into 3D bone models. \n The orthopedic implant maker Shoulder Innovations is the latest medtech to plan for a nine-figure IPO, as it looks to scale up its commercial reach. The Grand Rapids, Michigan-based company aims to raise about $100 million by offering 5 million shares on the New York Stock Exchange priced between $19 and $21 apiece. It plans to list under the ticker SI. Shoulder Innovations, founded in 2009, has received FDA green lights for its InSet implant systems for total shoulder joint replacements as well as reverse shoulder procedures, in cases where the rotator cuff is damaged. It also offers artificial intelligence-powered surgical planning software, the FDA-cleared ProVoyance, which translates CT images into 3D bone models. The company says its InSet platform can provide a more secure connection to the bone and reduce the mechanical stresses on the implant as the arm moves, while describing implant loosening as the leading cause of failure in shoulder arthroplasty, where about 250,000 procedures are performed annually in the U.S.In the future, it also plans to develop a revision solution and a fracture-specific system, as well as a line of implants for patients with a sensitivity to metals. In its filed prospectus, Shoulder Innovations reported preliminary financial results of about $21 million in revenue for the first six months of this year, up from $15.4 million for the same period in 2024. The company said it expects its net loss for that time to weigh in at about $24 million, up from last year’s $7.8 million—with the increase primarily due to rising operating losses as it expands its headcount, as well as second-quarter costs tied to changes in the fair value of its preferred stock warrant liability and a series E purchase option exercised in June. For the first quarter of 2025, the company recorded a net loss of $4.6 million, after revenue of $10.1 million.Earlier this week, Shoulder Innovations said it had closed a $40 million convertible notes financing backed by Fidelity Management; in March, the company announced its $40 million series E round, which was led by U.S. Venture Partners and joined by Gilde Healthcare Partners, Gilmartin Capital, Aperture Venture Partners, Arboretum Ventures and Sectoral Asset Management. Earlier this month, the AI coronary artery disease diagnostic developer Heartflow filed for a $100 million Nasdaq IPO after previously plotting a SPAC deal valued at $2.4 billion in 2021, which it abandoned the year after. Before that, the spine surgery devicemaker Carlsmed also aimed to raise more than $100 million.This year has also seen large public offerings from Kestra Medical Technologies, Beta Bionics and Caris Life Sciences, with its $494 million splash.

BOSTON--(BUSINESS WIRE)--Omega Funds, a leading international healthcare venture capital firm focused on delivering impactful medicines to patients, today announced the closing of its eighth fund with $647 million in capital commitments. The new fund, Omega Fund VIII, L.P. ("Fund VIII"), was oversubscribed, exceeding its target of $600 million, garnering strong support from both new and existing limited partners. With Fund VIII, the firm will continue to execute its strategy of creating and investing in innovative life sciences companies in the U.S. and Europe that target severe, unmet medical needs. Since its inception in 2004, Omega Funds has raised $2.5 billion to invest in exceptional entrepreneurs developing innovative products across multiple therapeutic areas, including oncology, immunology, rare diseases, medical devices, and precision medicine. Fund VIII builds upon the prior success of Omega Funds, resulting in 52 commercialized products being brought to market by Omega portfolio companies. The firm's investments have resulted in 50 exits via M&A, and 47 public listings. Omega’s recent M&A exits and IPOs include SoniVie (acquired by Boston Scientific), Scorpion Therapeutics (acquired by Eli Lilly), Kestra Medical Technologies (NASDAQ: KMTS), Beta Bionics (NASDAQ: BBNX), Upstream Bio (NASDAQ: UPB), Bicara Therapeutics (NASDAQ: BCAX), Morphic Therapeutic (NASDAQ: MORF, acquired by Eli Lilly), EyeBio (acquired by Merck), Imago BioSciences (NASDAQ: IMGO, acquired by Merck), Amunix Pharmaceuticals (acquired by Sanofi), and Chord Therapeutics (acquired by Merck KGaA). “We are very grateful to our investors for the support and trust, particularly given this exceptionally challenging fundraising environment. By exceeding its target size, Fund VIII is a recognition of our investment strategy and track record of consistent exits across market cycles,” said Otello Stampacchia, Founder and Managing Director of Omega Funds. “We appreciate the partnership from both our longstanding and new limited partners.” “As with prior funds, Fund VIII will support management teams in the U.S. and Europe through company creation, early venture rounds, and later-stage financings,” said Francesco Draetta, Managing Director of Omega Funds. “We believe our broad investment strategy is well-positioned for navigating this period of macro and policy uncertainty. We look forward to contributing our capital, expertise, and network connectivity in partnering with entrepreneurs, founders, co-investors, and the broader community to transform the standards of care for severe diseases.” About Omega Funds Founded in 2004, Omega Funds is a leading international venture capital firm that creates and invests in life sciences companies that target our world's most urgent medical needs. Omega focuses on identifying and supporting companies through value inflection points across the full arc of innovation, from company formation through clinical milestones and commercial adoption. Omega Funds' portfolio companies have brought 52 commercialized products to market in multiple therapeutic areas, including oncology, rare diseases, precision medicine, medical devices, and others. Please visit www.omegafunds.com for additional information.