Pear Therapeutics Inc. has joined a growing number of med-tech startups that are merging with special purpose acquisition companies (SPACs) as a backdoor pathway to an initial public offering (IPO). On Tuesday, Pear, a company developing digital therapeutics, reported plans to combine with Thimble Point Acquisition Corp., a blank check company affiliated with the Pritzker Vlock Family Office (PVFO), in a deal valued at approximately $1.6 billion. The $400 million in gross proceeds, including roughly $276 million in cash held in Thimble’s trust account and about $125 million, at $10 per share, from an oversubscribed PIPE (private investment in public equity), will be used to further commercialize Pear’s three FDA-authorized products, advance its pipeline and scale its end-to-end platform.
It’s not unusual for women to have some uterine contractions during pregnancy. Many of these go unnoticed, but others can be strong and feel like labor. Distinguishing between normal contractions and those that are not can help ensure women at risk of preterm labor get the extra medical care they need. To that end, Tel Aviv-based Nuvo Group Ltd. has launched an FDA-cleared uterine activity (UA) module on its Invu remote monitoring platform.
Diagnostics powerhouse Danaher Corp. has agreed to buy Aldevron LLC, a privately held biotech company that supplies a key ingredient for COVID-19 vaccines, from EQT VIII Fund for $9.6 billion in cash. Based in Fargo, N.D., with additional operations in Madison, Wis., Aldevron makes high-quality plasmid DNA, mRNA and recombinant proteins used in vaccines, gene and cell therapy, gene editing and diagnostic applications.
Livanova plc has launched an IDE trial of its Aura6000 sleep apnea device, following approval by the FDA to proceed with the study. The implantable pulse generator (IPG) is designed to treat patients with moderate to severe obstructive sleep apnea (OSA) who do not get relief from a traditional continuous positive airway pressure (CPAP) machine or refuse to use one.
The FDA granted breakthrough device designation to Volumetrix LLC for its NIVAHF monitoring system for heart failure. The device is the first application of the company’s noninvasive venous waveform analysis (NIVA) technology, which captures and analyzes vital information about blood volume to assess patient status.
Veracyte Inc. reported new data showing its Decipher Prostate genomic classifier can help to identify patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) who are more likely to benefit from treatment with Erleada (apalutamide) in addition to androgen-deprivation therapy (ADT). The study is the first to demonstrate Decipher Prostate’s prognostic utility in men with locally advanced prostate cancer.
Xenco Medical LLC debuted its glasses-free holographic surgical simulation platform, Holomedx, enabling patients and their surgeons to understand the nuances of spinal procedures before they get underway. The company will begin deploying the virtual reality (VR) training tool for nondiagnostic use at select sites during the week of June 14.
Eyeyon Medical Ltd. has won CE mark approval for its flagship product, Endoart, a synthetic implant that replaces the human endothelium, which the body can’t regenerate. Designed to treat chronic corneal edema, it could help to reduce the long wait times for human donor corneas. Approval was based on a first-in-human trials involving 22 patients who received Endoart implants and were followed for 24 months.
Precipio Inc. reported the launch of its Hemescreen anemia panel, part of a suite of diagnostic tests that run on the Hemescreen physician office laboratory (POL) testing system. The new panel is intended to help physicians tackle a difficult challenge – deciphering anemias of unknown cause.
Imagine an orthopedic implant that not only accelerates bone healing but also captures data to support real-time clinical decisionmaking. That’s the vision of Intelligent Implants Ltd., whose Smartfuse system recently won FDA breakthrough device designation. The first indication is for lumbar spinal fusions.
