Pear Therapeutics (Nasdaq:PEAR) announced today that it received STeP designation from the FDA for its Pear-010 product candidate.
Boston-based Pear Therapeutics designed its Pear-010 prescription digital therapeutic (PDT) candidate to provide a neurobehavioral intervention (virtual reality-delivered pain reduction) to patients 18 and older with acute postoperative and acute postprocedural pain.
The company said in a news release that it plans to utilize its PearCreate discovery and development platform to develop the Pear-010 PDT.
FDA’s Safer Technologies Program (STeP) voluntary program exists for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments and diagnostics.
The goal of STeP is to provide patients and healthcare providers with timely access to such devices by expediting their development, assessment and review while maintaining the standards for premarket approval, 501(k) clearance and de novo marketing authorization.
“We believe pain is well suited for treatment with a PDT because currently more than 50 million patients are left to choose between pain and treatment by opioids,” Pear Therapeutics CMO Yuri Maricich said in the release. “We applaud FDA for recognizing the need to help patients gain more timely access to treatments for conditions like pain.”