Shareholder letter;
Tampa, FL, January 6, 2023 — McapMediaWire — RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to obstructive sleep apnea patients, today provides a corporate update and letter to shareholders from CEO Tom Wood.
Dear RemSleep Shareholders,
2023 is shaping up to be an extremely pivotal year for RemSleep and I couldn’t be more excited for the Company due to how we are currently positioned going into the New Year. We have several key priorities, goals, and product updates that I’d like to share with our investors as we look out into the next six months.
Our first and primary goal is a successful 510K submission for the DeltaWave CPAP mask. As stated in previous press releases, we hired an extremely qualified Senior Director for Regulatory Compliance and Regulatory Submission in Judy Strzepek. Her prior experience, collaboration with our new testing partner (who specializes in respiratory class II medical device testing, cleaning, and validation), and expertise with the FDA procedures has already proven to be invaluable to the submission process. We successfully completed a key meeting with the FDA last month which reaffirmed our testing criteria, testing execution, and remaining testing plan going forward. DeltaWave testing remains on track and is expected to be completed by mid-February to mid-March. Upon completion, we plan on immediately submitting our finalized FDA 510k submission. On a separate but related note, we are excited to announce our next generation masks, servicing both consumer and institutional (hospital, clinics, nursing homes, etc.) markets, could be on the market much sooner than originally anticipated due to the regulatory guidance provided by Ms. Strzepek. Once the current version of DeltaWave is cleared by the FDA, RemSleep will now have a quicker pathway to clearance for subsequent generations of DeltaWave based on their functionality or changes made to the original version. This will result in saving the company significant time and money in the clearance process as well as getting these products to market.
In conjunction with our confidence in the 510K process, the company is ramping up its sales and marketing plan for the release of the patented DeltaWave mask and next generation masks. This plan includes: adding additional in house and 3rd party resources to further develop this plan and launch these products; evaluating and further developing existing distributor and industry partners for a successful, commercial launch; naming of the new, next generation products, as well as some yet to be announced products, so all remain consistent with the RemSleep branding; and finally, adding professional sales executives with product launch & industry experience. Prioritizing this plan in the first quarter will help ensure a successful, broad market launch of the DeltaWave and next generation products upon FDA clearance.
Business execution continues to be a constant priority. The Company remains in a healthy cash position and expects to have sufficient capital on hand to execute the business plan through the successful commercial launch of the aforementioned products. Please see our latest financial statements as filed with OTC Markets Group. Within the business execution realm, we have reassessed the CPAP inventory and initial sales plan and have pursued new sales channels to address this inventory and future sales. The CPAP industry had several key product recalls in a rather difficult time period where supply was already short and demand was soaring. While this created opportunity for immediate sales and exposure, it also created new concerns and hesitation for distributors and end users with respect to liability. We had a key customer, who represented a substantial volume of initial pre-sales for these CPAP machines, back out of an agreement as they waited for clarity from the industry concerning new approvals and regulations in light of the ongoing and/or developing recalls. The presold units thus became unexpected inventory. While a number of these units were subsequently sold to different customers, we carried significantly more inventory than planned and thus had to shift focus on new markets for these particular units. This issue is not unique to RemSleep and remains an ongoing, industry challenge. That being said, that shift in focus has created a new sales channel development and has restored our confidence in these CPAP sales. While it is too soon to formally announce this development, we will share it with investors as soon as it is prudent to do so from a regulatory and competitive, strategic standpoint. Besides the revenue impact for the Company, this shift of product out of inventory on the balance sheet will free up significant capital for the ongoing business execution through and past FDA clearance.
Finally, our next generation masks have shown strong, internal indications of relief from those suffering from Chronic Obstructive Pulmonary Disease (COPD) and/or Congestive Heart Failure (CHF) in conjunction with their sleep apnea. We plan to conduct formal, FDA clinical study/trials to prove efficacy of this relief from COPD and CHF. Currently, there are no sleep apnea/CPAP masks on the market with these multiple indications. Successful, clinical trials should give RemSleep a competitive advantage for a new market for traditional CPAP masks. Further, it will be a critical step in differentiating the superiority of RemSleep products in the marketplace and subsequently further the sales, marketability, and overall profitability of the RemSleep product lineup. From the beginning, the Company has had a goal of being acquired. This new market should dramatically enhance the overall value of RemSleep and sense of urgency to act for potential acquirers. We are currently evaluating potential hospitals and sleep centers for these future studies/trials.
We have come a long way through our successes and setbacks but we still have a lot of work to do. However, our path is clear and we will continue to focus on the business execution from here on out. There are additional goals and targets for the Company longer term, but let’s get through the FDA 510K process first and allow that clearance to continue to open doors for the Company. We continue to appreciate and value the input, patience, and loyalty from our shareholders. We have the right team in place, with the right products coming to the market at the right time, and a wonderful investor base. For those reasons, I am truly thankful and excited for this New Year. Now let’s get back to work!
