Femasys Inc. revised the design for its Femaseed pivotal trial to focus on couples experiencing male factor infertility, which accounts for about half of all cases of infertility today. Femaseed delivers sperm directly to the fallopian tube where an egg is released. As a result of the redesign, the Femaseed trial will need just one-quarter the number of treatment cycles originally anticipated.
Just as the U.S. FDA gathered industry leaders to address the issues posed by pulse oximeters that provide inaccurate measurements for individuals with darker skin, Biointellisense Inc. released its own FDA-cleared technology that provides accurate readings regardless of skin tone. The challenge of inaccurate readings for people with darker skin came to the fore with the COVID-19 pandemic as fingertip pulse oximeters emerged as a convenient method of monitoring for hypoxia at home and in clinics, but frequently overreported oxygen levels in the blood of people of color, leading to delayed treatment.
Johnson & Johnson (J&J) agreed to acquire circulatory support device maker Abiomed Inc. for $380 per share in cash, corresponding to an enterprise value of $16.6 billion and a more than 50% premium on the share price as of the market close on Oct. 31. Abiomed shareholders will also receive a non-tradeable contingent value right that entitles them to $35 per share in cash, if certain milestones are met. That would bring the premium to 60%.
It was a good week for companies focused on minimally invasive brain surgery. Monteris Medical Corp. received $35 million in a series D equity financing and a $38 million debt facility to support market adoption and clinical research on its Neuroblate system, a laser ablation system that provides a minimally invasive option for brain surgery. Nico Corp. also raised additional funds, with a $12.5 million oversubscribed round for its devices, which do not require cutting through the brain but instead use the natural folds of the brain to reach abnormalities.
Cresilon Inc. raised $25 million in a series A-4 financing round led by Paulson Investment Co. The funds will be used to commercialize its plant-based hemostatic gel for human applications and bring it to global veterinary markets. Known as Vetigel in animal medicine, the product is used by veterinarians to instantly stop bleeding in dental and surgical procedures and emergency situations in the U.S., U.K., Europe and Canada.
Ernst & Young’s (EY) annual Pulse of the Industry report offers plenty of reasons for optimism within med tech as the impact of the pandemic recedes, while identifying several key areas that will require continued focus for the sector’s long-term success.
Just days after taking the helm of Royal Philips NV, CEO Roy Jakobs told shareholders that the company plans to “immediately reduce our workforce by around 4,000 roles globally” as a result of multiple challenges that contributed to poorer than expected third quarter results. The company posted a net loss for the quarter, missing consensus, which it attributed to continuing supply chain issues and the deteriorating economic environment.
Ixlayer Inc. partnered with CVS Health Corp. to streamline lab testing, lower costs and provide actionable steps for patients through a new at-home testing service. Starting with vitamin D levels, Lyme disease, sexually transmitted infections and thyroid function, the collaboration will put a wide range of common lab tests on the pharmacy giant’s shelves and online service for consumers to buy without a prescription or doctor’s visit and at a reduced cost compared to conventional testing channels.
After years of aggressive acquisitions, Medtronic plc joined 3M Co., General Electric Co. and Johnson & Johnson in rationalizing its business by splitting into more focused enterprises. Medtronic will separate its patient monitoring and respiratory therapy groups into a new company with projected annual revenue of $2.2 billion and 8,000 employees in the next 12 to 18 months, assuming regulatory and final board approvals.