Recap includes transformational matters affecting the Company's position to manage impending growth
LAS VEGAS, NV / ACCESSWIRE / January 11, 2024 / CB Scientific. Inc. (OTCQB:CBSC) ("CBSC" or the "Company"), a designer, manufacturer and distributor of non-invasive ambulatory cardiac monitoring products and services, today is providing its shareholders with a 2023 year-end review from Charles Martin, Chief Executive Officer.
Although 2023 presented a number of challenges for CBSC, I am pleased to report that we have made progress on a number of impactful initiatives in support of our stated business plan.
Fundraising. Over the past 12 months, the Company has worked closely with a New York-based investment banking partner to raise $1.75MM in bridge financing. The intended use of proceeds from this fundraising activity is to acquire an Independent Diagnostic Testing Facility (IDTF) and expand its operations, continue ongoing product development activities, and complete other essential business activities to properly position the Company to uplist from the OTCQB Venture Market to a national exchange such as Nasdaq, NYSE, or the recently introduced Cboe. Confronted with challenging market conditions that seriously disrupted the normal liquidity cycle of traditional high-net-worth bridge financiers, the Company has alternatively consummated a series of small private equity sales to maintain a minimal level of development stage operations. We are diligently continuing to seek requisite capital from a range of prospective sources and remain optimistic that we will eventually succeed with our larger bridge financing endeavor.
Regulatory Clearance to Market. As previously reported, the Company tendered a 510(k) submission for Clearance to Market to the U.S. Food and Drug Administration (FDA) for its updated myCam cardiac event monitor product. Nearing the conclusion of the formal examination process, the FDA introduced certain new, previously undisclosed guidance documents pertaining to common emitters and cybersecurity for all medical devices, including our myCam product. In order to receive a substantial equivalency finding on our 510(k) submission, we were required to retool the device cable and the existing mold housing, then complete independent third-party testing to ensure the newly defined performance requirements were realized. The Company utilized the FDA pre-submission method to streamline the process and to identify any additional areas of concern that may exist. Employing the new eStar submission process we then formally resubmitted our 510(k) application in early December2023, and are hoping for a positive outcome, perhaps as early as the end of 1Q2024.
Business Acquisition. In July 2023, we successfully negotiated under favorable terms an asset purchase agreement to acquire a regional, well-established, 24/7/365 IDTF that currently provides a full assortment of products and support services for ambulatory cardiac monitoring devices prescribed by Cardiologists. The business was established in 1988 and maintains relationships with Medicare, Medicaid, and effectively all of the largest commercial 3rd party insurance payers. A successful closing would provide the Company with an immediate revenue stream, and would also establish a foundational platform upon which a nationwide coverage footprint could be constructed over the subsequent 18-24 months.
International Regulatory Trials. Beginning in March 2020, the Company commenced regulatory device and software trials in 48 hospitals across China. In August of 2023, we were asked to expand myCam product trials into 20 additional public and private hospitals located in Hong Kong and Macau. Through the conclusion of 2023, more than 4 million ECG patient interactions have been completed using our myCam devices producing an overall performance rating of 99.7%. Once the FDA 510(k) grants Clearance to Market for the myCam device, the Company intends to work with Shenzhen Pump Medical System Co., Ltd., our China-based manufacturing partner, to pursue domestic product Clearance to Market from the National Medical Products Administration (NMPA) in China.
Offshore Business. Subsequent to the FDA issuing 510(k) Clearance to Market for the myCam device, the Company will resume its ongoing product deployment initiatives in Thailand, Malaysia, Singapore, and Indonesia where initial support infrastructure has been previously established. Additionally, since FDA 510(k) Cleared-to-Market devices meet regulatory requirements for Hong Kong and Macau, the Company intends to pursue placement of the myCam device at the earliest possible opportunity. Additionally, following issuance of final FDA 510(k) clearance for the myCam product, the Company plans to promptly commence pursuit of regulatory clearance with Health Canada to support our new Canadian distributor, Your Heart Protector Corp., in their endeavor to pursue product placement throughout Canada.
Intellectual Property. In May of 2022, the Company announced that James Ott had been named our Chief Technology Officer. Besides his extensive expertise in bringing medical devices to market, Jim also presented the Company the opportunity to acquire from Freedom Cardio, LLC the rights to certain intellectual property prospectively referred to as Xnode. A Letter of Intent was subsequently effected which provided the Company a viable path to consummate the future purchase of the intellectual property, subject to the negotiation of definitive terms and conditions. A draft form Asset Purchase Agreement was then prepared with the assistance of legal counsel, and the parties agreed that final execution would be contingent upon approval by the Company's Board of Directors. In the interim, the parties informally agreed that the Company would fund certain ongoing development expenditures of the Xnode technology in exchange for reserving future exclusivity rights. The Company embraced this opportunity as it believes that eventual deployment of Xnode technology across the full range of ambulatory cardiac monitoring modalities promises to be highly disruptive to current industry product offerings. Additionally, successful acquisition of Xnode technology could provide the Company with licensing opportunities for product applications in various alternative commercial market segments including wearable devices, bedside monitoring, and clinical research trials.
Several of the aforementioned initiatives that may materially impact the Company's future are predicated on our success in raising $1.75MM in bridge financing, and as stated earlier, we remain hopeful that funding goal will be achieved. We look forward to what 2024 holds for the Company, and sincerely appreciate your continued support.
About CB Scientific, Inc.
CB Scientific, Inc., through its international subsidiaries, provides innovative products and services in the ambulatory non-invasive cardiac monitoring space. Our electrocardiogram (EKG) devices, interactive cloud-based acquisition software, and smartphone apps for both iOS and Android platforms provides improved compliance for patients at risk of abnormal heart rhythms, as well as more accurate information for physicians.
Company Contact Information:
Telephone: (888) 225-0870
Email: General Inquiries: info@cbscientificinc.com
Investor Inquiries: investor@cbscientificinc.com
Follow CBSC: Twitter, Facebook, Instagram, LinkedIn, YouTube, and Newsletter
This information disclosure may contain forward-looking statements covered within the meaning of the Private Securities Litigation Act of 1995. These forward-looking statements relate to, among other things, plans and timing for the introduction or enhancement of our services and products, statements about future market conditions, supply and demand conditions, and other expectations, intentions, and plans contained in this press release that are not historical fact and involve risks and uncertainties. Our expectations regarding future revenues depend upon our ability to develop and supply products and services that we may not produce today and that meet defined specifications. When used in this press release, the words "plan," "expect," "believe," and similar expressions generally identify forward-looking statements. These statements reflect our current expectations. They are subject to a number of risks and uncertainties, including, but not limited to, changes in technology and changes in pervasive markets. This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties, including, without limitation, the ability to obtain financing and regulatory and shareholder approval for anticipated actions.
SOURCE: CB Scientific, Inc.
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