Conformal seals $35M series D for ‘CLAASy’ LAAO device
Conformal Medical Inc. plugged the gap in funding needed to complete enrollment in the pivotal CONFORM trial for its left atrial appendage occlusion (LAAO) technology with completion of an oversubscribed $35 million series D fundraising round. The Conformal left atrial appendage seal (CLAAS) system is designed to close off the left atrial appendage in individuals with non-valvular atrial fibrillation to cut the risk of stroke and avoid the use of anticoagulants.

Conformal seals $35M series D for ‘CLAASy’ LAAO device
Conformal Medical Inc. plugged the gap in funding needed to complete enrollment in the pivotal CONFORM trial for its left atrial appendage occlusion (LAAO) technology with completion of an oversubscribed $35 million series D fundraising round. The Conformal left atrial appendage seal (CLAAS) system is designed to close off the left atrial appendage in individuals with non-valvular atrial fibrillation to cut the risk of stroke and avoid the use of anticoagulants.
Sparrow’s smartphone stethoscope gets FDA nod
The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.
Today's news in brief
BioWorld MedTech briefs for June 7, 2023.
Committee set up in France to assess diagnostic, prognostic and predictive technology
The French national authority for health (HAS) has provisionally set up CEDiag, a committee for assessing diagnostic, prognostic or predictive health technologies. This new national committee will cover the field of clinical procedures, including radiology, clinical biology and anatomo-cytopathology examinations, diagnostic drugs such as contrast agents used in medical imaging and radiopharmaceutical drugs, as well as medical devices such as self-testing kits.
FDA warning letters hint that med-tech compliance programs drifted during COVID
The U.S.FDA posted two warning letters to medical device manufacturers June 6, one each to Irhythm Technologies Inc., and Steiner Biotechnology LLC, and both warnings include citations for marketing for claims that are not in the FDA-reviewed product labels.
US Medicare program renders ‘landmark’ coverage memo for seat elevation devices
The U.S. CMS has wrapped up a coverage analysis for seat elevation systems that are accessories for power wheelchairs, but the agency went above and beyond the strict terms laid out in the proposed decision memo.

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Preventing opioid overdoses with a smart patch: Resilient Lifescience Inc. is developing a wearable patch that monitors vital signs and automatically administers naloxone when needed. Brad Holden, CEO of Resilient Lifescience, explained how the device works for overdoses as well as other potential applications for the new technology.

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Digital health

Digital therapeutics seen as effective, but reimbursement slow to materialize
Europe
There is a growing body of evidence showing prescription digital therapeutics (DTx) are effective, but slow progress in agreeing reimbursement and integrating them into care pathways is limiting access for patients and holding back commercial development in Europe.
Exai Bio MCED test shows high sensitivity for stage I cancer, machine learning detects gastric cancer
Conferences
Breakthroughs in early detection of cancer offer increasing hope for better outcomes and longer lives for individuals affected by malignancies. This year’s American Society of Clinical Oncology annual meeting highlighted strong results from several companies at the forefront of this potential...
China ramps up efforts to digitize health
Regulatory
China continues to ramp up efforts to digitize its health care system, as it moves closer toward a 2025 deadline that is part of a nationwide plan. Several of the country’s largest tech conglomerates now have digital health operations that are beginning to show profits and are expected to grow...
Machine models enhance cardiac surgery mortality risk prediction
Cardiovascular
Researchers at Mount Sinai Hospital have demonstrated that a machine learning-based model enables medical institutions to predict mortality risk for individual cardiac surgery patients.

Financings

Follow-on offerings up year-over-year as overall med-tech financing value continues decline
Analysis and data insight
Med-tech companies raised $8.65 billion in the first five months of the year, a decrease of 34.9% from the $13.29 billion raised in the same time frame last year. The number of deals is down 33.04% from last year, from 230 to 154.

Newco news

Orakl developing in vitro diagnostic test using organoids for colorectal cancer
Cancer
The Gustave Roussy cancer center, specializing in cancer treatment, and its technology transfer subsidiary Gustave Roussy Transfert, reported the creation of startup Orakl SA, which develops a technology for modeling cancer tumors called the patient tumor avatar. Orakl leverages a unique collection...

Startup Enhanc3D raises £10M for high-res genome mapping platform
Medical devices and technologies
Enhanc3D Genomics Ltd. has raised £10 million (US$11.3 million) in a series A round to advance development of its Genlink3D technology for directly linking gene regulators in non-coding DNA to their target protein coding genes.
Spinoffs keep up dizzying pace with Medtronic separation
U.S.
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...

Deals and M&A

Novo Nordisk negotiating takeover of insulin pen maker Biocorp
Diabetes
Novo Nordisk A/S has entered into exclusive negotiations for a controlling stake in Biocorp SA, suppliers of Mallya, a Bluetooth-enabled smart add-on device for insulin pen injectors. The takeover will be phased over several stages. Novo Nordisk has initially negotiated with Bio Jag SAS, Biocorp’s...
Avacta acquires Coris for £7.4M as it builds diagnostics business
Diagnostics
Avacta Group plc has continued its growth through M&A strategy with the acquisition of Coris Bioconcept Sprl, a developer of rapid diagnostic test kits, for an up-front cash consideration of £7.4 million (US$9.3 million). The Coris deal comes on the back of its £24 million purchase of Launch...
Freenome buys immunodiagnostics company Oncimmune for $16M
Acquisition
Freenome Inc. has acquired U.K.-based immunodiagnostics developer Oncimmune Ltd. for £13 million (US$16 million), in a move that bolsters Freenome’s frontline early cancer detection efforts. While Freenome has been largely focused on getting the U.S. FDA’s nod for its colorectal cancer test,...
Pear sliced into four parts at auction for $6M
Digital health
A financial freefall left prescription digital therapeutic pioneer Pear Therapeutics Inc. cut into four pieces following a bankruptcy judge’s approval of the sale of its assets for a total of $6.05 million. Sleep-focused Nox Health Group took the biggest bite, acquiring the FDA-cleared Somryst PDT...
Boston Scientific abandons $230M purchase of M.I. Tech due to pressure from regulators
U.S.
Boston Scientific Corp., has announced that it has abandoned its plans to acquire M.I. Tech Co. Ltd., of South Korea after opposition was announced by the U.S. Federal Trade Commission (FTC). The FTC lauded the news with a May 24 statement that cited the agency’s cooperation with other national...

Europe

Reports says UK government needs to speed up approval of med-tech devices
Regulatory
The U.K. government should speed up the approval process for medical devices and strengthen the Medicines and Healthcare products Regulatory Agency, as there is an opportunity for the country to provide global leadership in life sciences regulation in medical devices and medicines on the back of...

Asia-Pacific

Endoangel’s AI-based diagnosis system for endoscopy is approved in China
Regulatory
Wuhan Endoangel Medical Technology Co. Ltd.’s artificial intelligence (AI)-assisted real-time quality control and auxiliary diagnosis system for lower gastrointestinal endoscopy has been approved by China’s NMPA.

China grants marketing approval for a hybrid intravascular imaging system
Regulatory
Grand Pharmaceutical Group Ltd. obtained China’s NMPA approval for an intravascular dual-mode imaging system for coronary artery imaging, tapping into a potentially huge but very undeveloped market for imaging in percutaneous coronary interventions (PCI).
BIO Korea 2023: South Korean government funds keep innovators afloat during VC deep freeze
The venture capital market in South Korea is frozen shut, said presenters during the recent BIO Korea 2023 conference in Seoul, but Korea’s Medical Device Development Fund will help support domestic R&D efforts to the tune of ₩987 billion (US$738 million) over five years.

Clinical

Creo’s Microblate Flex poised to provide early lung cancer detection
Cancer
Creo Medical Group plc says it is poised to address the mismatch between the advances in screening technology, which are making it possible to detect early-stage lung cancer, and the current invasive and inappropriate methods of treating it,...
Biosency’s technology detects acute chronic obstructive pulmonary disease early
Respiratory
Biosency SA's Bora Care remote monitoring solution can predict acute chronic obstructive pulmonary disease (COPD) exacerbations on average three days prior to hospitalization, according to initial results from an ongoing study. The results show...
Treatment with Endogenex device eliminates the need for insulin in type 2 diabetes
Diabetes
A one-hour procedure pioneered by Endogenex Inc. could make insulin use obsolete in people with type 2 diabetes. The recellularization via electroporation therapy (ReCET) procedure uses a specialized catheter to deliver electric pulses to the...
Study shows Exact benefit of early cancer diagnosis
Exact Sciences Corp.’s long-term analysis of results from the Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing (DETECT-A) study found that all patients diagnosed and treated for stage I or II cancers...
Renal denervation, the comeback kid
Renal denervation (RDN) was described as the “comeback kid” at the recent EuroPCR conference in Paris where participants argued that following the success seen in several sham-controlled trials, there is now no doubt about the safety and the...
Magnus Medical’s Saint system alters brain signals in patients with severe depression
Results from a new study suggest that treatment with Magnus Medical Inc.'s Saint neuromodulation system causes abnormal brain signals to become normal by reversing the direction brain signals flow in severely depressed individuals. The researchers...

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