Significant adjustment in outlook compared to the December Update
2/15/2024 COB Update, condensed version, Red notes are my opinion
Clinicals in Progress
Surgical Analgesia - UCSD 120 patients, estimated end date 3/20/2024, "primary outcome measures being pain levels and opioid consumption measured", "the study will be able to assess the efficacy of our model 088 in not only reducing the acute surgical pain and opioid use". (sounds like this study would meet the 'No Pain Act' requirement for proof of reducing opioid consumption)
Thumb Arthritis - Stanford 60 patients, standard device was modified for thumb use, estimated completion April/may 2024 (hard to find a more respected name in medical research than Stanford)
Clinicals in peer Review
Post-Amputation Pain - UCSD, under review for 'Regional Anesthesia and Pain Journal', presentation will occur at their March conference ( UCSD's Dr Illfeld is a well respected researcher with over 100 published papers, medical professionals take notice of this work)
Canine Osteoarthritis - Showed 96% significant improvement, under review for 'Veterinarian Medicine and Science Journal', packaging for a Veterinarian product has been ordered (BIEL being proactive to capitalize on this publication)
Manufacturing
Redesign of the manufacturing process for increased reliability and shelf life, proof of concept production run of the RecoveryRx ES has been done, test marketing in near future (BIEL sounds confident that the Recovery RX ES will not face any significant regulatory hurdles)
Sales
The Dr Berend, Chief medical Officer of Ortho Alliance, presentation at the Musculoskeletal Care Symposium was based on all branches of the Ortho Alliance adopting use of the RecoveryRx (OrthoAlliance currently has 180+ physicians and more than 2,000 employees. Its partners now include 12 practices across Ohio, Kentucky, and Indiana)
Several Domestic and International distributor negotiations are in progress, the range from the final approval and registration stage to the initial exploration stage
(those in those in the 'final approval and registration' stage could happen any time now)
Legal Action
Mundipharma violated a 5 year contract to order a minimum of $14 million in BIEL devices, legal representation has been engaged in the US and Singapore to look into a lawsuit for this breach of contract (we know what happened to Mundipharma, caught up in the Sackler opioid lawsuits, but this does not absolve them of contractual obligations)
