Biomérieux scales AMR focus through new joint venture
Biomérieux SA is stepping up investments in the antimicrobial resistance (AMR) space through a new new €40 million ($40.75 million) joint venture with Evotec SE and Boehringer Ingelheim GmbH. The companies are teaming up to launch a new company, Aurobac Therapeutics SAS which will develop AMR diagnostic tests and antimicrobial therapies.

Biomérieux scales AMR focus through new joint venture
Biomérieux SA is stepping up investments in the antimicrobial resistance (AMR) space through a new new €40 million ($40.75 million) joint venture with Evotec SE and Boehringer Ingelheim GmbH. The companies are teaming up to launch a new company, Aurobac Therapeutics SAS which will develop AMR diagnostic tests and antimicrobial therapies.
No negative impact on infant development with alternative to classic IVF
A study published in Human Reproduction showed no developmental delays in children conceived using capacitation-in vitro maturation (CAPA-IVM) compared to those born through conventional in vitro fertilization (IVF). Researchers with Lavima Fertility Inc. presented the results at a July 6 session of the European Society of Human Reproduction and Embryology in Milan, Italy.
Stakeholders see disclosure risk in FDA’s voluntary improvement program
The U.S. FDA’s efforts to improve medical device quality includes a recent draft guidance that pertains to the pilot version of a voluntary improvement program, but stakeholders see a number of critical issues with the draft. A coalition of device makers said this pilot program should include disclosure guardrails that parallel similar guardrails provided for medical device reports (MDRs), a provision related to discovery during product liability litigation that is seen as critical if device makers are to take part in the voluntary improvement pilot.
Volpara, Microsoft team up to quantify breast arterial calcification to identify heart risk
Volpara Health Technologies Ltd. joined forces with Microsoft Corp. to accelerate the research and development of software that uses mammograms to identify potential cardiovascular issues.
Today's news in brief
BioWorld MedTech's briefs for July 6.
Radiopharma Clarity touts advantages of its targeted copper theranostics
Clarity Pharmaceuticals Ltd. is progressing three of its targeted copper theranostics through the clinic that are based on its sarcophagine technology that securely holds copper isotopes inside a cage-like structure, called a chelator. The SAR technology allows a unique pairing of copper isotopes, copper-64 and copper-67, for both cancer diagnosis and therapy.
FTC affirms order for Fiagon divestiture for Medtronic/Intersect acquisition
The U.S. Federal Trade Commission (FTC) affirmed its proposed order to force Intersect ENT Inc., of Menlo Park, Calif., to divest itself of Fiagon AG before Dublin-based Medtronic plc., can complete its acquisition of Intersect. The announcement comes as no surprise, but serves as a reminder that the FTC is standing by previous threats to tightly control the mergers and acquisitions market in the U.S., a policy stance that has been duplicated in the European Union.
UK’s Oxford launches pandemic institute to prepare for future threats
Oxford University has opened the doors to its new Pandemic Sciences Institute, a £100 million (US$119.5 million) initiative to build on the research and experience of COVID-19, to counter future pandemic threats.

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Digital health

A fertile field: Aivf raises $25M as Fairtility receives CE mark
Financings
Two Israeli companies aiming to improve in vitro fertilization (IVF) success rates received good news recently, with Aivf Ltd. hauling in $25 million in a series A round for Ema, its IVF software platform, and Fairtility Ltd. gaining CE mark for its CHLOE EQ embryo quality decision-support tool.
Consortium launches Oncolab to standardize access to oncology data
Cancer
A French public-private consortium of seven med-tech companies, research institutes and specialist cancer hospitals is launching a new project to standardize and improve access to health care data for cancer research. Paris-based Arkhn SAS and Owkin SAS joined forces with INRIA, the French national...
Envision unveils AI-powered glasses for the blind, visually impaired
Ophthalmic
Envision Technologies BV’s latest artificial intelligence (AI)-powered smart glasses for the blind and visually impaired are designed to help with reading, scanning faces and navigating everyday tasks. This visual assistant was introduced at California State University Northridge (CSUN) 2022...
GE Healthcare launches continuous monitoring system to catch signs of patient deterioration
Europe
If GE Healthcare’s GM of Monitoring Solutions Neal Sandy gets his way, nursing staff will perk up and notice a newly launched wireless patient monitoring system that helps them detect patient deterioration much earlier than periodic, manual monitoring.

Financings

Axbio nets $100M in financing for sequencing technology development
Private
Axbio Inc. raised nearly $100 million in a series B round for the development of its sequencing technology.

Newco news

University of Birmingham spin-off eyes ocular surface disease market
Ocular
A technology developed at the University of Birmingham, U.K., has been spun off as a potential treatment for ocular surface diseases. The platform technology from startup Healome Therapeutics Ltd. was developed by a team of material scientists at the University’s Healthcare Technologies Institute...

Satellite Bio goes into orbit with $110M VC funding for bioengineered tissue tech
Satellite Biosciences Inc. has become the latest biotech to emerge from stealth, backed with more than $110 million in VC financing to develop bioengineered tissues that fix damaged tissues or organs. With former Novartis executive Dave Lennon leading as CEO, the Cambridge, Mass.-based company is...
Pangea Biomed reels in $7M for pan-cancer response predictor
Financings
Pangea Biomed Ltd. picked up $7 million in seed financing to fast-track development of its multicancer, multitherapy response predictor Enlight. The platform combines machine learning and RNA sequencing to map tumor molecular signatures and predict how different cancer types will respond to...

Deals and M&A

Orthocell inks global deal with Biohorizons for dental collagen membrane worth $16M
License
Orthocell Ltd. landed its first global licensing deal for its regenerative collagen medical device with Biohorizons Inc., one of the largest dental implant companies in the world. The licensing deal comes on the heels of the Perth, Australia-based company reporting final data from its nerve...
Pfizer revises Resapp offer on heels of failed data confirmation study
Coronavirus
Pfizer Australia Holdings Pty Ltd. has revised its offer to acquire digital health company Resapp Health Ltd. after results from an independent data confirmation study of its COVID-19 algorithm failed to meet Pfizer’s required sensitivity and specificity results.
Prognomiq partners with KSM to discover cancer biomarkers
Cancer
Prognomiq Inc. secured access to 800,000 anonymized biological samples for analysis and detection of dynamic cancer biomarkers as part of a new partnership struck with Kahn-Sagol-Maccabi (KSM), the research and innovation center of Maccabi Healthcare Services, Israel’s largest health maintenance...
Trajan completes AU$29.7M placement to acquire Chromatography Research Supplies
Acquisition
Medical device and analytics company Trajan Group Holdings Ltd. completed an AU$29.7 million (US$20.7 million) placement to fund the acquisition of Louisville, Kentucky-based Chromatography Research Supplies Inc.
Nonagen lands CE mark for Oncuria bladder cancer test
Regulatory
Los Angeles-based cancer diagnostics company Nonagen Bioscience Corp. obtained CE marking for its Oncuria immunoassay for bladder cancer. The multiplex urine test is designed to detect the concentration of 10 proteins that are associated with bladder cancer in urine samples. Clinical studies found...

Europe

Ukrainian patients receive Humacyte HAVs for traumatic injuries
Humacyte Inc. provided its Human Acellular Vessel (HAV) implants to Ukrainian hospitals on the front-line of the Russian invasion as part of the company’s humanitarian relief initiative. Two patients have received the implants for treatment of vascular trauma injuries. One patient had sustained a...

Asia-Pacific

China’s NMPA gives green light to Ocumension’s Yutiq intravitreal implant for uveitis
Regulatory
China’s National Medical Products Administration (NMPA) approved Ocumension Therapeutics Ltd.’s and Eyepoint Pharmaceuticals Inc.’s drug-device combination product, Yutiq (fluocinolone acetonide intravitreal implant), for chronic non-infectious uveitis affecting the posterior segment of the eye.

Samsara expands footprint in China for prosthetic eye devices with partner Lansheng Medical
Deals and M&A
Samsara Vision Inc. signed a deal with China’s Lansheng Medical Corp. (Myvision) to bring Samsara’s next-generation visual prosthetic devices to mainland China, Macau, the Hanain Province, and Hong Kong.
India updates regulations on licenses as part of regulatory overhaul
Regulatory
India’s regulators have made more moves in recent times as part of its larger and ongoing movement to regulate medical devices in its country. The Ministry of Health and Family Welfare has just finalized its regulations over the licenses of medical device manufacturers and suppliers.

Clinical

Immunovia advances diabetes study for pancreatic cancer blood test
Cancer
Immunovia AB is progressing a study evaluating its Immray Pancan-d blood test for the early detection of pancreatic cancer in patients with new onset type 2 diabetes. Studies have found that type 2 diabetes is a major risk factor for developing...
Philips reveals positive 3-year data for Tack endovascular system for critical limb ischemia
Conferences
After three years of clinical research, Royal Philips NV said its Tack (4-F) endovascular system has shown promising results for arterial dissection repair following balloon angioplasty in patients with critical limb ischemia and infrapopliteal...
New study signals potential of uniting AI and radiologists
A new large-scale study has found combining artificial intelligence (AI) and radiologists to analyze breast cancer screenings can lead to better patient outcomes, when compared with unaided radiologists and the use of AI alone. The study,...
Axogen aims for surgeon uptake of nerve graft following RECON results
With top line results from its major phase III RECON study in hand, Axogen Inc. is hoping to expand adoption of its allograft nerve repair product Avance. RECON was designed as a non-inferiority study comparing Avance to nerve cuffs (manufactured...
Penumbra presents new data for blood clot removal system
Europe
Penumbra Inc. presented new data at the LINC Symposium in Leipzig, Germany, evaluating its Indigo aspiration system for submassive pulmonary embolism (PE). The subgroup analysis evaluated performance outcomes of patients with main pulmonary artery...
Sophia Genetics teases early data for AI lung cancer study
Conferences
Sophia Genetics SA shared preliminary findings from its multimodal Deep-Lung-IV clinical study at the 2022 American Society of Clinical Oncology annual meeting. The study is utilizing Sophia’s cloud-based, artificial intelligence diagnostic...

BioWorld MedTech Perspectives

Goldilocks or bust: The FDA’s regulatory harmonization dilemma
BioWorld MedTech
We’ve been hearing for several years about an FDA proposal to overhaul its device regulatory framework with ISO 13485, potentially the most ambitious FDA...
Forward to the past: The FDA commissioner dilemma
BioWorld MedTech
As we’ve all undoubtedly noticed, the FDA commissioner’s chair is conspicuously absent a duly deputized occupant, and a number of reasons have been offered...
U.S. politicking threatens public trust in the FDA and CDC
BioWorld MedTech
The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to...
The demise of the device tax and other fun med-tech stories
It’s mighty tempting to run a little play on words with regard to eyesight in this new year, but I need reading glasses, so far be it from me to pepper a...
Missed Opportunity: The epidemic of poor sleep
BioWorld MedTech
There are a lot of ways to save money without going bankrupt in the process, but health care in the U.S. certainly has not lent itself to that sort of...
Next up for TAVR: bicuspid valve
BioWorld MedTech
Now that the existing inventory of FDA-approved transcatheter aortic valve replacement (TAVR) devices has received a green light for patients at low...
Cabanas and commissioners; med tech in the news
BioWorld MedTech
We who write about medical devices rarely suffer for content, but the month of May was unusually cooperative even by our standards. Following are two...

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