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FDA grants STeP designation for Pear Therapeutics’ neurobehavioral digital therapeutic

FDA grants STeP designation for Pear Therapeutics' neurobehavioral digital therapeutic

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Pear Therapeutics (Nasdaq: PEAR) announced today that it has received STeP designation from the Food and Drug Administration (FDA) for its Pear-010 product.

Boston-based Pear Therapeutics has designed its Pear-010 Digital Therapeutic Candidate (PDT) to deliver a neurobehavioral intervention (pain reduction via virtual reality) to patients 18 years of age or older who experience acute and acute postoperative pain after surgery.

The company said in a press release that it plans to leverage the PearCreate Discovery and Development platform to develop the Pear-010 PDT.

The 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 therapies and diagnostics.

The goal of STeP is to provide patients and healthcare providers with timely access to these devices by accelerating their development, evaluation, and review while maintaining standards for premarket approval, 501(k) clearance and new marketing authorization.

“We believe that pain is well suited to treatment with PDT because currently more than 50 million patients are left to choose between pain and opioid treatment,” Pear Therapeutics CMO Yuri Maricich said in the statement. “We commend the Food and Drug Administration for recognizing the need to help patients access timely treatments for conditions such as pain.”

BTIG analyst Marie Thibault writes in a report that a neurobehavioral intervention with PDTs represents a “significant market opportunity,” with Pear acquiring rights to some index-related assets from First Hand Technology.

“We believe this STeP designation is an important win for Pear and a step in the right direction to expand its platform beyond psychiatry to include adjacent market aspects such as neuroscience,” Thibault wrote.

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