U.S. FDA Grants 510(k) Clearance for Spectral’s DIMI - Seite 2

Current DIMI Market Opportunities:

As Dialco prepares to extend the indication for DIMI to include both home and PD use, Dialco will focus on the chronic dialysis centers and long-term care facilities markets.  These segments offer promising markets where DIMI can offer unique advantages over current products in this space.

• According to the CDC, there are approximately 15,600 skilled nursing facilities (“SNFs”) in the U.S. providing care to approximately 1.7 million residents;
  
  
• An estimated 74,000 dialysis patients live in SNFs, with the majority traveling to dialysis centers to receive treatment;
  
  
• Installation of easy-to-use dialysis machines in SNFs could help reduce risks of patient travel to clinics, reduce overall costs of care and provide a new source of revenue for the SNF;
  
  
• Existing U.S. SNF markets represent an estimated US$2 billion market annually (combined devices and disposables).

Dialco’s key operating activities to commercialize DIMI in the near term will focus on gaining clinical acceptance of DIMI amongst nephrologists and nurse practitioners, given the importance of peer reference in the dialysis industry.  Some of the key activities include:

• DIMI evaluations at SAMI early adopter customer sites;
  
  
• Addition of three additional clinical/academic sites in the U.S. and Canada over the next six months;
  
  
• Initiate pilot evaluations in SNFs;
  
  
• Ramp up sales activity; and
  
  
• Develop a complete product portfolio (by adding ancillary disposables) for the DIMI system.   

Remaining Regulatory Pathway:

While the U.S. SNF market is a significant opportunity, the Dialco team is focused on unlocking the full commercial capabilities of DIMI, which includes both home and PD use.  The regulatory pathway forward will be on a stepwise basis, with key regulatory activities and milestones laid out below:

FDA Approvals:

• FDA home HD usability and safety trial in Q4 2020.  This will be a required six-month, 25-patient safety and usability trial which tests the ability of non-medical professionals to assist the patient in setting up and running the dialysis treatment;
  
  
• PD FDA 510(k) submission expected in Q4 2020.  This enables patients to use DIMI for automated PD treatments at home, especially for those who are transitioning from PD to home HD;
  
  
• Special FDA 510(k) application for remote monitoring software submission expected in Q1 2021.  This unlocks the full remote monitoring software suite, allowing physicians to remotely check-in and adjust a patient’s treatment regime;