Anual Information FormI expect Spectral's management will try and hide from addressing the loss of control of DIMI nd SAMI in the Anual Information Form due out in the next week or so...
So let's take a look at how they represented DIMI and SAMI in last years Anual Information Form below (March 23rd 2022, bold added)
From it we can gain insights into how much shareholder money was spent on DIMI and SAMI, how many announcements were made to raise money off of DIMI/ SAMI, and how many "material information" discloures were made re: DIMI and SAMI.
Let's see if continue tell shareholders that the loss of control is not material or any of our business- but here are some of the receipts...
Description and development
The Company entered into the RRT business by acquiring the rights to SAMI, an easy-to-use dialysis machine on which to use its PMX cartridges, from Infomed S.A. (“Infomed”). The Company entered into a manufacturing and supply agreement with Infomed on December 1, 2018. The agreement expires on December 31, 2026, with a provision to extend it for additional two-year terms.
SAMI complements the PMX/EAA™ development as it can be used to deliver the Company’s therapy in the ICU and reduces reliance on third party instrumentation. This state-of-the-art equipment will enable the Company to provide a fully integrated and user-friendly septic shock treatment system to the ICU. In addition, SAMI is also designed to provide an open platform for other hemoperfusion cartridges and to deliver continuous renal replacement therapy (“CRRT”) when indicated for patients with acute kidney injury.
On December 13, 2017, the Company received 510(k) clearance from the FDA for SAMI for use in CRRT and therapeutic plasma exchange (“TPE”). Since it is also designed as an open platform hemoperfusion delivery device, the Company intends to seek further 510(k) clearance for this purpose when there is an FDA approved hemoperfusion cartridge available for use in the U.S. market, including potentially the Company’s PMX treatment.
On February 18, 2018, the Company announced that HC approved SAMI, under License No. 100541 for use in CRRT, TPE, as well as for Hemoperfusion (“HP”), a modality specifically designed to facilitate patient treatment with the PMX cartridge.
On March 8, 2018, SAMI received a CE mark in Europe for the same applications.
The Company has exclusive license rights for SAMI in North America for all CRRT applications and has worldwide exclusivity for any hemoperfusion applications.
Spectral transferred its RRT business to its wholly owned subsidiary, Dialco Medical Inc. (“Dialco”) in 2019.
On March 18, 2019, Dialco entered into a development, license and exclusive distribution agreement with Infomed to extend its license to include the North American exclusive rights to an easy-to-use home hemodialysis machine (“DIMI”), built on the same platform as SAMI. The Company is seeking to obtain regulatory approval for DIMI in Canada and the United States for in-home use. DIMI is already CE marked for hemodialysis in Europe by Infomed.
On August 31, 2020, the Company received FDA 510(k) clearance for DIMI to treat patients with acute and/or chronic renal failure with or without fluid overload using hemodialysis (“HD”), hemofiltration (“HF”) and/or ultrafiltration (“UF”) in hospital or clinical settings. This is the first major step of the full regulatory development of DIMI. Further advances will be clearance for home and peritoneal dialysis use. Dialco also submitted an application to HC to add DIMI as a new product under the SAMI family of products.
On November 11, 2020, the Company announced that a paper reporting on the deployment and use of its SAMI unit during the COVID-19 pandemic was published in the Journal of Blood Purification, titled, “Deployment of a new CRRT/PIRRT device during the COVID-19 pandemic emergency: organizational challenges an implementation results”. The paper describes the first month of using SAMI as part of UMMC’s PIRRT (Prolonged Intermittent Renal Replacement Therapy) program throughout April 2020. The installation and training were successfully managed remotely with SAMI utilized to treat 23 patients in the 11 first 4 weeks. The paper goes on to state, “The results from the nurse questionnaire, as well as the successful deployment of the SAMI in our institution during the pandemic with only 3-hour virtual training support that operating the SAMI is simple and safe. The setup of the SAMI has been refined to be as simple as possible, and interactions that normally cause issues (connecting the bloodline to the various safety sensors and pumps) have been refined to almost a single gesture of inserting the disposable cassette into the machine. This approach together with a comprehensive self-testing procedure allows the unit to eliminate as many potential user errors as reasonably possible.”
Also in November 2020, the Company announced that Dialco received its Medical Device Single Audit Program (“MDSAP”) certification for “the design, manufacture, installation and service of equipment for extracorporeal blood purification and its related disposable”. MDSAP allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirement of multiple regulatory jurisdictions or authorities to enable appropriate regulatory oversight of medical device manufacturer’s quality management systems while minimizing the regulatory burden on the industry.
On February 23, 2021, the Company announced that Dialco received IDE authorization by the FDA to conduct a usability trial to demonstrate the safety and efficacy of DIMI for performing hemodialysis in the home environment. The trial is expected to enroll 35 patients, and will analyze delivered dialysis dose and potential adverse events happening during six weeks of use at home compared to six weeks of use in the hospital setting on some patients.
On March 31, 2021, the Company announced that Dialco received its license from HC for the DIMI RRT system. The HC license for DIMI is indicated for hemodialysis, hemodiafiltration and ultrafiltration for patients weighing 20 kgs or more, and can be used in hospitals, clinics and at home.
On April 8, 2021, the Company announced that Dialco entered into an expanded, long-term licensing agreement with Infomed for the DIMI hemodialysis system, extending Dialco’s exclusive rights in the United States and Canada through 2041. The initial term of the agreement shall extend to December 31, 2026 (“Initial Term”), and the agreement will automatically extend for three additional five-year periods (“Renewal Terms”).
On June 7, 2021, the Company announced that Dialco engaged CROMSOURCE, a full-service Contract Research Organization (“CRO”), for its upcoming DIMI IDE usability clinical trial. CROMSOURCE is a high quality, ISO certified international provider of outsourced clinical trial services that has been a trusted partner to pharmaceutical, medical device, and biotechnology companies for more than 20 years.
On January 31, 2022, the Company announced Dialco received approval of a protocol amendment to its DIMI usability trial from the FDA. This protocol amendment allows for both improved patient and clinical logistics flow in conducting the DIMI trial.
Competition
The North American CRRT market key players are Baxter and NxStage with other companies contributing a small percentage, including Nikkiso and B Braun. Baxter’s approach to the CRRT market includes a legacy machine (“Prismaflex”) and the next generation machine (“Prismax”) that have the possibility of running multiple therapies with multiple customization options. NxStage’s approach to the CRRT market includes a very simple low maintenance machine (“NxStage System One”). This machine is witnessing a rising adoption in North America due to its low maintenance requirements and ease of use for ICU nurses, when compared with Baxter’s Prismaflex and Prismax. However, System One adoption is limited due to the lack of flexibility in running different CRRT modalities as compared to both Prismaflex and Prismax.
As a next generation machine platform, Spectral’s SAMI and DIMI were developed to be flexible in their applications, and easy to use and maintain.
COMMERCIALIZATION INITIATIVES
SAMI continues to be launched in Canada and the U.S. for use as a RRT machine. It continues successful clinical evaluation in key hemodialysis centres and building its commercialization pipeline. As hospitals are experiencing a significant shortage of CRRT machines in COVID-19 affected ICU’s, there has been increased activity with respect to the use of SAMI in the treatment of COVID-19 positive patients. The Company has successfully developed remote installation, set-up and high-level on-line training of SAMI.
In order to support commercial expansion, and in anticipation to the start-up of the DIMI usability trial, Dialco is expanding its field force for sales training and technical support. Dialco has one field force resource in Ontario, and four employees in the U.S. The U.S. field force employees are located in Pennsylvania, Florida, Michigan, and California. Recruitment initiatives continue for further U.S. field force expansion in targeted states.
TRENDS
As described above, the Company believes that there is an opportunity to pursue the commercialization of SAMI in the broader CRRT market.
MANUFACTURING
The SAMI and DIMI are manufactured by Dialco with the initial assembly performed by Infomed.
More can be found at Sedar.com search under Spectral Medical AIF March 23, 2022