Remarkable milestones for three life sciences start-ups

Another of Odne’s products has received clearance from the U.S. Food & Drug Administration. Odne Clean is an endodontic debridement device, offering a novel approach to root canal disinfection, simplifying and accelerating the process. It creates a hydro-dynamic cavitation cloud inside the root canal using only saline solution (sodium chloride) as the main irrigation medium. The cavitation jet removes debris inside the canals and tubules and increases the effect of the final disinfection rinse with NaOCl.

OdneClean has the potential to reduce the risk of adverse events caused by harsh chemical disinfectants commonly used during root canal disinfection. With its 190 µm tip, the thinnest dental fluid-delivery tip on the market, OdneClean supports minimally invasive root canal treatments enabling endodontists and dentists to preserve as much tooth structure as possible. In 2023, Odne received FDA-clearance for OdneFill, its root canal obturation technique. OdneFill is the first light-curing root canal filler that instantly photo-cures upon applying OdneCure, a high-precision laser curing light.

Piomic’s COMS devices gets further validation
Piomic’s flagship product, the COMS (Concurrent Optical and Magnetic Stimulation) One Therapy System, is a portable, hand-held device designed to promote the healing of hard-to-heal wounds. It synergistically applies optical and magnetic stimulation externally to wounds, providing a non-invasive approach. The device has shown promising results in clinical trials. Most recently, the August edition of the Journal of Wound Care (JWC) featured a new study about COMS led by Dr. Jacques Neyens and Prof. jos schols in the Netherlands, further validating the remarkable results of Piomic’s COMS® technology. This case series, involving 27 patients treated with COMS at the Expertise Centre for Wound Care (ECW) in Oosterhout, reinforces the positive results observed in the startup’s original pivotal trial and in real-world usage, demonstrating the effectiveness of COMS beyond the clinical setting. COMS® demonstrated impressive wound surface reduction, with positive effects across all wound types treated.

IVDR for SOPHiA GENETICS' DDM platform
Another notable achievement in the realm of health care innovation is the receipt of a CE Mark certification for SOPHiA GENETICS’ DDM Platform under the European Union's In Vitro Diagnostic Regulation (IVDR). The Platform analyzes complex genomic and multimodal data and generates real-time, actionable insights for a broad global network of hospital, laboratory, and biopharma institutions. Powered by SOPHiA GENETICS' proprietary deep learning algorithms, the Platform supports state-of-the-art oncology technologies, including five existing CE-IVD SOPHiA DDM applications. Moreover, the Platform uses the collective intelligence gathered by SOPHiA GENETICS' global network of partners and, to date, has facilitated the analysis of more than 1.7 million genomic profiles.

IVDR certification is a significant regulatory milestone that validates the powerful analytical capabilities of the SOPHiA DDM Platform and allows customers throughout the European Union and other markets recognizing this certification to use the SOPHiA DDM Platform to support patient diagnostics.

(Press release/RAN)