Solana Company (HSDT) Status Update summary

CMS Reimbursement and Pricing Update

• CMS set reimbursement for the PoNS Mouthpiece at $2,963.30 effective January 1, 2025, but the company is seeking a correction to approximately $5,000 based on market and contract pricing rather than discounted cash pay rates.

• Controller reimbursement was preliminarily set at $519.80, mapped to a TENS device, which is contested as inappropriate; the company argues for $11,000 based on market comparables.

• The company is challenging CMS's methodology and pursuing further engagement to correct pricing before the January 1, 2025, effective date.

• Delays and uncertainty in CMS decisions have hindered commercial ramp, delayed access for MS patients, and negatively impacted financial stability and market value.

• Ongoing efforts include meetings and appeals to CMS, with optimism for a resolution by January or April 2025.

Strategic Alternatives and Market Outlook

• The company has initiated a process to explore strategic alternatives, including partnerships, mergers, acquisitions, or asset sales, to maximize shareholder value due to market access delays and financial constraints.

• B. Riley Securities has been engaged as a financial advisor to support the evaluation of options.

• Current market cap (~$2 million) and public company costs challenge continued Nasdaq and SEC compliance, but there is no intent to delist.

• The company is exploring options to support the business without further equity raises under current conditions.

Product Development and Regulatory Overview

• PoNS is a non-implantable, orally applied device delivering neurostimulation via a mouthpiece, used with physical rehabilitation to improve balance and gait.

• In the US, PoNS is indicated for short-term treatment of gait deficit due to mild-to-moderate MS symptoms, as an adjunct to supervised exercise for patients 22 and older.

• PoNS is authorized in Canada for stroke, traumatic brain injury, and MS-related gait and balance deficits, and in Australia for short-term use to improve balance and gait.

• The system has FDA clearance for MS gait deficit and is progressing toward stroke indication, with pivotal study enrollment on track for completion and submission in H1 2025.

• VA and a major private insurer have recognized fair pricing and reimbursement for PoNS, supporting ongoing market access efforts.