Hard to say what sort effect this will have on the price..but it is a great step.
You'd also think Baxters weigh behind this as a PMX partner helps
IDK but If you've thought about jumping in here ever, this might be the time...
up 20% this AM
Forward-looking statement
You'd also think Baxters weigh behind this as a PMX partner helps
IDK but If you've thought about jumping in here ever, this might be the time...
up 20% this AM
US FDA Grants Spectral Medical Breakthrough Device Designation for Toraymyxin(TM) ("PMX") for the Treatment of Endotoxemic Septic Shock
Breakthrough designation expected to help accelerate regulatory review
TORONTO, July 11, 2022 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that the US Food & Drug Administration (“FDA”) has granted Breakthrough Device designation for the Company’s Toraymyxin™ (“PMX”) device, a therapeutic hemoperfusion device that removes endotoxin, which can cause septic shock.
The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.
Dr. John Kellum, Chief Medical Officer of Spectral, commented, “For over 50 years the medical scientific community has sought a treatment for sepsis, yet today, no specific therapies are available. A new therapy showing survival benefit for the most severely affected patients would indeed be a breakthrough technology and we are pleased to see that the FDA agrees.”
“We are entering an era of personalized medicine for critical illnesses,” continued Dr. Kellum. “By breaking up sepsis into subsets that have specific molecular pathogenesis, we believe our strategy targeting endotoxemic septic shock, characterized by high levels of endotoxin in the bloodstream, is far more likely to succeed, where other non-specific therapies have failed time and again. Our goal is to show a large difference in mortality when an anti-endotoxin therapy is applied to carefully selected patients with high endotoxin activity in their bloodstream. Moreover, we have a diagnostic test already in clinical use to identify these patients. We believe this combination of an advanced diagnostic with a specific therapy represents the future of sepsis care.”
Chris Seto, CEO of Spectral, stated, “We are honored and grateful to the FDA for granting Breakthrough Device status for PMX. While our clinical trial is still underway, clinical data both within and outside the trial are highly encouraging and we believe PMX has the potential to provide hope for patients suffering from this devastating illness, as endotoxin often leads to multiple organ failure and death. In fact, approximately 120,000 patients each year suffer from endotoxemic septic shock, with an estimated 50% mortality rate. In turn, we estimate this translates to a $1.6 billion annual market for PMX in the U.S. alone. Our current TIGRIS Phase 3 confirmatory trial is continuing to progress, with over a quarter patients out of a planned 150 patients randomized to date. We also believe this trial is significantly de-risked given the prior clinical data from our EUPHRATES trial. Importantly, we believe this Breakthrough Device designation will help accelerate review by the regulators upon completion of the TIGRIS trial. Moreover, we continue to work closely with Baxter, our exclusive commercial partner in the U.S. and Canada, in order to prepare for commercialization, assuming the trial is successful, and we receive regulatory approval.”
About FDA Breakthrough Devices Program and Breakthrough Designation
The Breakthrough Devices Program was established to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.
About Spectral
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 340,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.
Dr. John Kellum, Chief Medical Officer of Spectral, commented, “For over 50 years the medical scientific community has sought a treatment for sepsis, yet today, no specific therapies are available. A new therapy showing survival benefit for the most severely affected patients would indeed be a breakthrough technology and we are pleased to see that the FDA agrees.”
“We are entering an era of personalized medicine for critical illnesses,” continued Dr. Kellum. “By breaking up sepsis into subsets that have specific molecular pathogenesis, we believe our strategy targeting endotoxemic septic shock, characterized by high levels of endotoxin in the bloodstream, is far more likely to succeed, where other non-specific therapies have failed time and again. Our goal is to show a large difference in mortality when an anti-endotoxin therapy is applied to carefully selected patients with high endotoxin activity in their bloodstream. Moreover, we have a diagnostic test already in clinical use to identify these patients. We believe this combination of an advanced diagnostic with a specific therapy represents the future of sepsis care.”
Chris Seto, CEO of Spectral, stated, “We are honored and grateful to the FDA for granting Breakthrough Device status for PMX. While our clinical trial is still underway, clinical data both within and outside the trial are highly encouraging and we believe PMX has the potential to provide hope for patients suffering from this devastating illness, as endotoxin often leads to multiple organ failure and death. In fact, approximately 120,000 patients each year suffer from endotoxemic septic shock, with an estimated 50% mortality rate. In turn, we estimate this translates to a $1.6 billion annual market for PMX in the U.S. alone. Our current TIGRIS Phase 3 confirmatory trial is continuing to progress, with over a quarter patients out of a planned 150 patients randomized to date. We also believe this trial is significantly de-risked given the prior clinical data from our EUPHRATES trial. Importantly, we believe this Breakthrough Device designation will help accelerate review by the regulators upon completion of the TIGRIS trial. Moreover, we continue to work closely with Baxter, our exclusive commercial partner in the U.S. and Canada, in order to prepare for commercialization, assuming the trial is successful, and we receive regulatory approval.”
About FDA Breakthrough Devices Program and Breakthrough Designation
The Breakthrough Devices Program was established to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.
About Spectral
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 340,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
Forward-looking statement
Informationinthisnewsreleasethatisnotcurrentorhistoricalfactualinformationmayconstituteforward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior managementaswellasinformationcurrentlyavailabletoit.Whiletheseassumptionswereconsideredreasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results aresubjecttoanumberofrisksanduncertainties,includingtheavailabilityoffundsandresourcestopursueR&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
Contact:
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
Contact:
| Mr. Blair McInnis | Mr. Ali Mahdavi | David Waldman/Natalya Rudman |
| CFO | Capital Markets & Investor Relations | US Investor Relations |
| Spectral Medical Inc. | Spinnaker Capital Markets Inc. | Crescendo Communications, LLC |
| 416-626-3233 | 416-962-3300 | 212-671-1020 |
| bmcinnis@spectraldx.com | am@spinnakercmi.com | edt@crescendo-ir.com |
UP 14% on 630K
Spectral Medical Provides Update on Tigris Clinical Trial
T.EDT | 12 hours agoProvides positive case study on patient enrolled at University of Michigan
14 clinical sites actively enrolling patients with 40 patients now randomized
14 clinical sites actively enrolling patients with 40 patients now randomized
TORONTO, July 20, 2022 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly-owned subsidiary Dialco Medical Inc. (“Dialco”), today provided a clinical trial update on Tigris, a follow-on study designed to build on knowledge gained from the earlier EUPHRATES trial, evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock. The Tigris trial end point is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care.
Key Tigris Trial Updates:
Key Tigris Trial Updates:
- First patient enrolled at the University of Michigan (“U of M”) trial site
- 40 patients randomized to date out of the 150 total patients to be enrolled in the Tigris trial
- Recruitment steadily rising with 14 trial sites actively screening patients and open for enrollment
Dr. John Kellum, Chief Medical Officer of Spectral, stated, “I am pleased to report our trial site at the University of Michigan has randomized their first patient. The clinical staff at U of M witnessed immediate improvement in the patient’s status following administration of PMX and the patient was able to transfer out of the intensive care unit (ICU) sooner than expected. We believe this positive patient outcome, and the fact that data thus far is exceeding expectations, reinforces our prior EUPHRATES trial data and our overall confidence in the efficacy of PMX in this patient population.”
Kyle Gunnerson, MD, FCCM, Professor and Emergency Medicine Director at the Emergency Critical Care Center within the University of Michigan, further noted, “My team and I were very encouraged with the effectiveness of PMX in our first randomized patient within the Tigris trial. We saw rapid improvement and recovery in the patient following administration of PMX and, importantly, the patient was transferred out of the ICU sooner than we anticipated with full discharge from the hospital in under two weeks from admission. With no FDA approved sepsis solution on the market, PMX has the potential to become an effective solution for sepsis and vital for clinical care use around the world. Following the successful treatment of our first randomized patient, my clinical team and I look forward to enrolling more patients into this important study.”
“We are making significant progress with our Tigris confirmatory trial and are very encouraged by the data thus far,” commented, Chris Seto, Chief Executive Officer of Spectral Medical. “PMX targets a large unmet medical need that is currently estimated at $1.6 billion in the U.S. alone. With no approved or cleared treatments on the market, we believe, if Tigris is successful, we can swiftly move towards FDA submission, which follows our recent Breakthrough Device designation granted by the FDA. With continued progression of the Tigris trial, our Breakthrough Device designation, as well as our executed commercial partnership with Baxter, we remain laser focused on our goal of bringing PMX to market. Most importantly, we believe PMX will provide new hope for the approximately 120,000 patients each year that suffer from endotoxemic septic shock and face an estimated 50% mortality rate.”
About Spectral
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 340,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxemic septic shock. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
Forward-looking statementKyle Gunnerson, MD, FCCM, Professor and Emergency Medicine Director at the Emergency Critical Care Center within the University of Michigan, further noted, “My team and I were very encouraged with the effectiveness of PMX in our first randomized patient within the Tigris trial. We saw rapid improvement and recovery in the patient following administration of PMX and, importantly, the patient was transferred out of the ICU sooner than we anticipated with full discharge from the hospital in under two weeks from admission. With no FDA approved sepsis solution on the market, PMX has the potential to become an effective solution for sepsis and vital for clinical care use around the world. Following the successful treatment of our first randomized patient, my clinical team and I look forward to enrolling more patients into this important study.”
“We are making significant progress with our Tigris confirmatory trial and are very encouraged by the data thus far,” commented, Chris Seto, Chief Executive Officer of Spectral Medical. “PMX targets a large unmet medical need that is currently estimated at $1.6 billion in the U.S. alone. With no approved or cleared treatments on the market, we believe, if Tigris is successful, we can swiftly move towards FDA submission, which follows our recent Breakthrough Device designation granted by the FDA. With continued progression of the Tigris trial, our Breakthrough Device designation, as well as our executed commercial partnership with Baxter, we remain laser focused on our goal of bringing PMX to market. Most importantly, we believe PMX will provide new hope for the approximately 120,000 patients each year that suffer from endotoxemic septic shock and face an estimated 50% mortality rate.”
About Spectral
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 340,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxemic septic shock. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
Informationinthisnewsreleasethatisnotcurrentorhistoricalfactualinformationmayconstituteforward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior managementaswellasinformationcurrentlyavailabletoit.Whiletheseassumptionswereconsideredreasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results aresubjecttoanumberofrisksanduncertainties,includingtheavailabilityoffundsandresourcestopursueR&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
Contact:
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
Contact:
| Mr. Blair McInnis | Mr. Ali Mahdavi | David Waldman/Natalya Rudman |
| CFO | Capital Markets & Investor Relations | US Investor Relations |
| Spectral Medical Inc. | Spinnaker Capital Markets Inc. | Crescendo Communications, LLC |
| 416-626-3233 | 416-962-3300 | 212-671-1020 |
| bmcinnis@spectraldx.com | am@spinnakercmi.com | edt@crescendo-ir.com |
I think a financing on Spectral is inevitable here in the next few weeks...Might be a good time to buy after the deal is announced.
Money till October left in the coffers and these guys have shown in the past they don't like cutting it close..
I'd also guess the trail partner for Dimi will be announced shortly...DaVita hopefully..I'd bet on it.
****Outset...Interesting the way this company has unraveled....down another 15% today I could see them needing to go back to the FDA for another round of Human Factor Testing on the machine. Crushing blow but great for Spectral.
CASE DETAILS: The filed complaint alleges that defendants made false statements and/or concealed that: (1) the Company's flagship product, Tablo Hemodialysis System ("Tablo"), would require an additional 510(k) application to be filed with The United States Food and Drug Administration ("FDA"), as defendants had "continuously made improvements and updates to Tablo over time since its original clearance"; (2) as a result, the Company could not conduct a human factors study on a cleared device in accordance with FDA protocols; (3) the Company's inability to conduct the human factors study subjected the Company to the likelihood of the FDA imposing a "shipment hold" and marketing suspension, leaving the Company unable to sell Tablo for home use; and (4) as a result, defendants' positive statements about the Company's business, operations, and prospects were materially false and misleading and /or lacked a reasonable basis at all relevant times.
OM LAWSUIT ALERT: Levi & Korsinsky Notifies Outset Medical, Inc. Investors of a Class Action Lawsuit and Upcoming Deadline (prnewswire.com)
Money till October left in the coffers and these guys have shown in the past they don't like cutting it close..
I'd also guess the trail partner for Dimi will be announced shortly...DaVita hopefully..I'd bet on it.
****Outset...Interesting the way this company has unraveled....down another 15% today I could see them needing to go back to the FDA for another round of Human Factor Testing on the machine. Crushing blow but great for Spectral.
CASE DETAILS: The filed complaint alleges that defendants made false statements and/or concealed that: (1) the Company's flagship product, Tablo Hemodialysis System ("Tablo"), would require an additional 510(k) application to be filed with The United States Food and Drug Administration ("FDA"), as defendants had "continuously made improvements and updates to Tablo over time since its original clearance"; (2) as a result, the Company could not conduct a human factors study on a cleared device in accordance with FDA protocols; (3) the Company's inability to conduct the human factors study subjected the Company to the likelihood of the FDA imposing a "shipment hold" and marketing suspension, leaving the Company unable to sell Tablo for home use; and (4) as a result, defendants' positive statements about the Company's business, operations, and prospects were materially false and misleading and /or lacked a reasonable basis at all relevant times.
OM LAWSUIT ALERT: Levi & Korsinsky Notifies Outset Medical, Inc. Investors of a Class Action Lawsuit and Upcoming Deadline (prnewswire.com)
Very Interesting ! One company's misfortune, can be another company's fortune.
Agree that financing news could come soon. At least now they have clearance (in the form of a recent weighted average SP) to be above the last one in 2021. Still holding out some hope that a DIMI Trial partnership, might come with a bit of a cash infusion (for equity or future distro rights or ROFR)..at least that's what I would be pushing hard for in negotiations if I were the CEO. Would certainly reduce the amount of dilution. But it would also necessitate carving out a value for Dialco and or a spin-out. Part of me believes that is a big reason behind delays to a Dimi Trial start. Other reasons could be they want to avoid the problem that Outset ran into.
Agree that financing news could come soon. At least now they have clearance (in the form of a recent weighted average SP) to be above the last one in 2021. Still holding out some hope that a DIMI Trial partnership, might come with a bit of a cash infusion (for equity or future distro rights or ROFR)..at least that's what I would be pushing hard for in negotiations if I were the CEO. Would certainly reduce the amount of dilution. But it would also necessitate carving out a value for Dialco and or a spin-out. Part of me believes that is a big reason behind delays to a Dimi Trial start. Other reasons could be they want to avoid the problem that Outset ran into.
I did not know that. If they are the "confirmed" "participant #2", this could get very interesting quickly. There are just so few players in this space (HD). Any likelihood that PMX gets approved (HP) would be complimentary to Dialco as well (with SAMI being HP capable with no one else having that capability, and of course the ability of patients to graduate from SAMI (in clinic) to DIMI (at home) with little adjustment). Sepsis is one of the leading causes of AKI.
Outset Medical stock skyrockets on resumed Tablo shipments
Still a rehashed machine..old techStock trading at $ 19 and change
AUGUST 1, 2022 BY SEAN WHOOLEY
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The news of the shipment hold’s end was enough to counteract Q2 earnings misses, sending OM shares up 21.5% at $18.77 per share in midday trading. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.6%.
In June, the company announced that it was holding shipments of its Tablo hemodialysis system for home use as a result of a pending FDA review and clearance of a 510(k) submitted for changes made since the Tablo system’s original March 2020 clearance.
Last month, it was revealed that the company would face a shareholder lawsuit claiming that the company and its top executives made false and misleading positive statements leading up to the shipment hold announcement.
However, in announcing its second-quarter results, Outset confirmed that the FDA has cleared the system changes, allowing shipments of Tablo for home use to resume.
For the quarter, the San Jose, California–based company posted losses of $43.8 million, or 92¢ per share, on sales of $25.1 million for the three months ended June 30, 2022, for a more than $13 million bottom-line slide on a sales dip of 0.6%.
Adjusted to exclude one-time items, losses per share were 77¢, 7¢ behind Wall Street, where analysts were looking for sales of $27.5 million.
“We are pleased to begin supporting new patients in the home again and helping them achieve autonomy and control over where and when they dialyze,” Outset Chair and CEO Leslie Trigg said in a news release. “As we look to the second half of the year, we see no change in underlying demand for Tablo. However, we have reflected in our guidance the staffing and inflationary pressures our provider customers are facing, as well as the work we need to do to regain commercial momentum following release of the Tablo ship hold.”
Outset said it now expects to bring in revenues between $105 million and $110 million, representing growth of 2% to 7% year-over-year.
Spectral Medical Announces that its Wholly-Owned Subsidiary Dialco Medical and Distribution Partner Marathon Medical Awarded Contract to Provide SAMI Dialysis Devices to the US Department of Veterans Affairs
T.EDT | 53 minutes ago
TORONTO, Aug. 08, 2022 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly-owned subsidiary Dialco Medical Inc.(“Dialco”), today announced that Dialco, along with its distribution partner, Marathon Medical Corporation, have been awarded a five year Indefinite Delivery/Indefinite Quantity (IDIQ) contract to provide SAMI CRRT (chronic renal replacement therapy) dialysis devices and associated maintenance services to the United States Department of Veterans Affairs’ (VA) national healthcare system.
The United States Department of Veterans Affairs is a government agency responsible for providing healthcare and other services to veterans. The VA initiated the solicitation of bids in order to streamline the purchasing and contract process, as well as provide enhanced product choices for VA healthcare professionals. Upon review, SAMI was selected and added to the approved product list for VA healthcare facilities nationwide.
Sam Amory, President of Dialco, commented, “We are proud to have our SAMI device selected by the VA and added to the approved product list for healthcare professionals. This selection followed an evaluation of our technology, and successful demonstration of our ability to meet the stringent specifications of the VA, including safety, efficacy, and ease of use. Importantly, our open platform design offers the opportunity for RRT cost control and therapy customization. SAMI also provides clear visuals with an easy-to-read display and rapid set up, which reduces the burden on healthcare staff. Marathon is an ideal partner on this five year IDIQ contract, as they have a successful track record supporting the market with new medical devices and a reputation for timely delivery of supplies. We believe the receipt of this contract award is an important milestone towards accelerating the commercial rollout of our SAMI device.”
Jon Landis, Chief Operating Officer of Marathon, stated, “We are excited to partner with Dialco to improve healthcare outcomes for America’s veterans. SAMI provides an alternative, user friendly and cost effective option to healthcare providers, medical centers and hospitals. We are honored to receive this important contract and look forward to supporting VA medical centers with this innovative healthcare solution.”
About Marathon Medical
Founded in 2022 by Vietnam era veteran, John St. Leger, Marathon Medical is a leading medical supply distribution company and veteran-owned small business, with a focus on federal government customers. Its mission is to provide excellence to the health care supply chain with professional personal service. Marathon Medical works with a variety of manufacturers to provide solutions for every department within the hospital. Marathon works to increase the number of reputable manufacturers that are recommended by VA physicians and purchasing clients. For more information, please visit: www.marathonmed.com.
About Spectral
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 340,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxemic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
The United States Department of Veterans Affairs is a government agency responsible for providing healthcare and other services to veterans. The VA initiated the solicitation of bids in order to streamline the purchasing and contract process, as well as provide enhanced product choices for VA healthcare professionals. Upon review, SAMI was selected and added to the approved product list for VA healthcare facilities nationwide.
Sam Amory, President of Dialco, commented, “We are proud to have our SAMI device selected by the VA and added to the approved product list for healthcare professionals. This selection followed an evaluation of our technology, and successful demonstration of our ability to meet the stringent specifications of the VA, including safety, efficacy, and ease of use. Importantly, our open platform design offers the opportunity for RRT cost control and therapy customization. SAMI also provides clear visuals with an easy-to-read display and rapid set up, which reduces the burden on healthcare staff. Marathon is an ideal partner on this five year IDIQ contract, as they have a successful track record supporting the market with new medical devices and a reputation for timely delivery of supplies. We believe the receipt of this contract award is an important milestone towards accelerating the commercial rollout of our SAMI device.”
Jon Landis, Chief Operating Officer of Marathon, stated, “We are excited to partner with Dialco to improve healthcare outcomes for America’s veterans. SAMI provides an alternative, user friendly and cost effective option to healthcare providers, medical centers and hospitals. We are honored to receive this important contract and look forward to supporting VA medical centers with this innovative healthcare solution.”
About Marathon Medical
Founded in 2022 by Vietnam era veteran, John St. Leger, Marathon Medical is a leading medical supply distribution company and veteran-owned small business, with a focus on federal government customers. Its mission is to provide excellence to the health care supply chain with professional personal service. Marathon Medical works with a variety of manufacturers to provide solutions for every department within the hospital. Marathon works to increase the number of reputable manufacturers that are recommended by VA physicians and purchasing clients. For more information, please visit: www.marathonmed.com.
About Spectral
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 340,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxemic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.
Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
