A rash of recent announcements in the diabetes market speak to the brisk pace of developments and keen competition in the field. Dexcom Inc. reported good news in the U.K. and Europe, offset by delays in the U.S., while Insulet Corp. gave investors assurance that it was moving full speed ahead in the release of its Omnipod artificial pancreas system. On the pharma side, Arecor Therapeutics plc signed a contingent agreement to acquire Tetris Pharma Ltd. and commercialize Ogluo in the U.K., E.U. and other countries.
Perkinelmer Inc. agreed to divest three businesses in a sale to private equity firm New Mountain Capital for $2.45 billion in cash to create a “pure-play, high growth, high margin life sciences and diagnostics company with unique scale,” said Perkinelmer president and CEO Prahlad Singh.
Dyansys Inc. obtained its second greenlight from the FDA this month for its Primary Relief device to alleviate pain following caesarean-section birth. The company received 510(k) clearance for its First Relief system for painful diabetic neuropathy on July 18. Both systems stimulate nerves on the outer surface of the ear using a percutaneous electrical nerve stimulator (PENS) system.
Better Therapeutics Inc. reported that the pivotal trial for its BT-001 prescription digital therapy (PDT) demonstrated significant decreases in hemoglobin A1c at 90 days that improved further at 180 days in participants with type 2 diabetes. The study showed a clear dose-response between greater use of the PDT and improvements in blood glucose levels.
Exo Inc. acquired Medo Dx Pte, an artificial intelligence (AI) developer, to make its point-of-care ultrasound imaging even easier to use. Medo brings two FDA-cleared artificial intelligence algorithms that draw on a library of millions of ultrasound images and health data to expand the settings for ultrasound and the reduce the expertise required for its use. Terms of the deal were not disclosed.
The U.S. FDA gave the greenlight to Acufocus Inc. for its IC-8 Apthera intraocular lens (IOL) for the treatment of cataracts. Like most other IOLs implanted as part of cataract surgery, the small aperture Apthera provides excellent distance vision. It distinguishes itself by also providing clear intermediate and near vision, essentially eliminating the blurring of close objects or words common as people age and develop presbyopia.
Cleerly Inc. sees a bright future ahead after boosting its fundraising to date nearly five-fold with a $192 million series C. The new infusion brought the total invested in the company to $248 million, a solid endorsement of a company that hopes to transform cardiology with precision-based diagnostics that move away from indirect indicators to accurate measurements.
The U.S. FDA handed good news to Healthy IO Ltd. (Healthy.io) with 510(k) clearance for its smartphone-based Minuteful Kidney test, making kidney function testing – from sample to result – possible at home. The app calculates the albumin-to-creatinine ratio (ACR), a key indicator of kidney disease. By enabling people to complete the test using their phones, the company says it has increased the rate of testing in high-risk patients by 50%.
Nanostics Inc. launched a new trial of its Claritydx Bladder with support from Alberta Innovates to the tune of C$600,000 (US$465,690). The test uses extracellular vesicle detection technology and artificial intelligence to identify bladder cancer and could provide a valuable alternative to cystoscopy for detection of bladder cancer at earlier stages.
Pillar Biosciences LLC hopes to build a stronger foundation for its multi-cancer in vitro diagnostic, Oncoreveal Dx. The company filed a supplemental application for U.S. FDA premarket approval of eight additional types of cancer, which the agency accepted for review. The assay received FDA premarket approval for use in non-small cell lung cancer (NSCLC) and colon cancer in August 2021.
