The medical devices industry has grown in importance over the course of the past decade or so, and investors are increasingly looking into innovative companies in the sector. A company from the sector that could be tracked this morning is RemSleep Holdings Inc. (OTC:RMSL), which made a major new announcement last Friday. The company is involved in manufacturing devices that could change the face of obstructive sleep apnea treatment.
On October 6, it announced that it had submitted the DeltaWave mask for 510K review to the United States Food and Drug Administration. RemSleep Holdings announced that it had suffered from a range of delays owing to industry recalls, the coronavirus pandemic, and third-party testing that necessitated the retesting of some tests. Hence, it was exciting to have finally submitted the DeltaSleep mask to the FDA for the 510K approval process.
The Chief Executive Officer of the company, Tom Wood, spoke about the development as well. He noted that it was a source of considerable excitement as well as relief that the company could finally announce that it was definitely moving ahead with the DeltaWave product. He went on to state that although the company had its fair share of setbacks, It went forward with the review since it had been confident about the safety and superior performance of DeltaWave in comparison to the regular masks on the market.
However, perhaps more importantly, Wood stated that, due to the skills of its Senior Director for Regulatory Compliance, Judy Strzepek, everyone at the company was confident that all the necessary information had been provided to the regulatory agency. Although he hastened to add that the management was not in a position to anticipate if the FDA was going to have follow-up questions about the product, Strzepek’s experience with regulations had been pivotal in the testing protocol design process. That could help in mitigating the necessity for further requests from the agency.
The company made another critical announcement on September 25 that investors ought to be aware of. At the time, the company not only provided an update about an agreement with new investors but also came up with an update about DeltaWave submission. RemSleep Holdings announced that it entered into a purchase agreement with Janbella Group LLC. Wood noted at the time that as the company moved into the phase of production, sales, and marketing of the product DeltaWave, it had decided to secure fresh capital through an agreement with Janbella Group.
He went on to add that the agreement would provide the company with access to capital by way of equity at market price as and when it may be necessary in the future. At the time, it was also announced by Wood that RemSleep Holdings expected to file the above-mentioned 510k filing for DeltaWave at the end of the week or the start of the following week. It was also noted that the company remained optimistic and excited about the future prospects of the DeltaWave mask.