Houston, Texas and Tuebingen, Germany, October 24, 2023 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced that its IMA203 TCR-T program has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA Center for Biologics Evaluation and Research (CBER) in multiple relapsed and/or refractory HLA-A*02:01-positive and PRAME-expressing cancers, including cutaneous melanoma, uveal melanoma, endometrial carcinoma, synovial sarcoma, and ovarian cancer. IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors.

“The FDA RMAT designation for multiple indications underscores the broad potential of IMA203 and the benefits it may provide for advanced-stage solid tumor patients. This is an important regulatory milestone and a recognition of our clinical development progress for this program,” said Cedrik Britten, Chief Medical Officer of Immatics. “The close support from the FDA resulting from the RMAT status enhances our efforts to accelerate bringing IMA203 to cancer patients by enabling real-time discussions on patient populations, trial design and CMC.”

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation programs. An investigational cell therapy is eligible for RMAT designation if it meets the definition of regenerative medicine therapy, it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with the FDA that may be used to discuss potential surrogate or intermediate endpoints for accelerated approval and potential ways to satisfy post-approval requirements, potential priority review of the biologics license application (BLA) and other opportunities to expedite development and review.

Based on publicly available information¹, it is the Company’s understanding that this is the first time that FDA has granted a RMAT designation for an oncology drug candidate for more than two solid tumor indications. As of Sep 30, 2023, the U.S. FDA has received at least 238 requests for RMAT designations and granted 92².

About IMA203 and target PRAME
ACTengine® IMA203 T cells are directed against an HLA-A*02:01-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers, thereby supporting the program’s potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogeneously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform, XPRESIDENT®. Through its proprietary TCR discovery and engineering platform XCEPTOR®, Immatics has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine® IMA203.

ACTengine® IMA203 TCR-T is currently being evaluated in three ongoing Phase 1b dose expansion cohorts in last-line patients: Cohort A IMA203 GEN1 monotherapy, Cohort B IMA203 in combination with an immune checkpoint inhibitor (deprioritized) and Cohort C IMA203CD8 GEN2 monotherapy, where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor.

About ACTengine®
ACTengine® is a personalized cell therapy approach for patients with advanced solid tumors. The patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor. The approach is also known as TCR-engineered cell therapy (TCR-T). All Immatics’ ACTengine® product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine® T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth.

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Las Vegas, October 10, 2023 – Sidekick Health, a global leader in digital health innovation, is poised to transform the landscape of digital therapeutics with the strategic acquisition of aidhere, a leading developer of prescription digital therapeutics (PDT) based in Germany.

In a significant move that underscores Sidekick Health’s commitment to furthering the impact of digital healthcare, the company is thrilled to announce its expansion into the direct prescribing space working collaboratively with healthcare providers.

This acquisition brings with it zanadio, one of the most successful PDTs launched to date. zanadio has fulfilled over 50,000 prescriptions and is recognized within Germany’s regulated  nationwide DiGA (Digitale Gesundheitsanwendungen) formulary for prescribable digital apps. Achieving long-term behavioral change and significant weight loss of 8% in patients at the end of 12 months^[1], and with over 10,000 doctors prescribing it, zanadio is fully reimbursed for patients with a BMI from 30 to 40 kg/m². As a permanently approved DiGA, zanadio is reimbursed by all statutory health insurers in Germany.

Sidekick Health’s CEO, Dr. Tryggvi Thorgeirsson, shared that the decision to acquire aidhere was fueled by the shared PDT vision and cultural alignment of the two organizations. “Developing and distributing prescribed therapeutics has always been core to our long-term vision, and when we were introduced to aidhere’s remarkable products and exceptional team, we knew that joining forces was the right step to take,” said Thorgeirsson.

This strategic acquisition places Sidekick Health at the forefront of the industry, while presenting exciting opportunities for the introduction of a new offering to Payer partners in the US, and the co-development of prescription digital therapeutic products with global pharmaceutical partners.

By integrating aidhere’s expertise and products into its portfolio, Sidekick Health strengthens its position as a trusted partner for global health insurers and pharmaceutical giants as it pioneers the introduction of PDTs.

In addition to the newly formed PDT business, Sidekick Health’s business is primarily centered on two areas: payers in the US and global pharma. Within the US payer landscape, the company has notably collaborated with the largest US health insurer, and is live with US insurance partners in Medicare, Medicaid and commercial populations. In the pharmaceutical sector, it has cultivated strategic partnerships with industry giants like Pfizer and Eli Lilly, with multiple live programs in both the US and Europe, and expanding to more markets in 2024.

The acquisition brings together the passion, knowledge, and experience of two industry leaders. Sidekick Health’s robust digital health ecosystem, a patient-centric platform with multi-chronic capabilities that supports over 20 disease areas, coupled with aidhere’s expertise in highly-regulated PDTs, creates a synergy poised to redefine patient-centric care. With its platform approach, Sidekick Health is positioned to emerge as a natural consolidator in the digital therapeutics space.

“aidhere has a strong and respected track record within the digital health industry, with one of the most successful PDT products in the world. This acquisition brings market-leading products and a depth of expertise in prescription digital therapeutics to Sidekick, as we enhance and build on our patient care offerings in the digital health and therapeutics space with our global partners,” said Thorgeirsson.

Sidekick Health’s recent success in closing its Series B fundraising round in May 2022 laid the foundations for the company to accelerate innovation and drive even greater impact in the digital health and therapeutics sector. Notable investors in Sidekick Health include Novator Partners, Asabys Partners, Frumtak Ventures, and Wellington Partners.

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Cambridge, Mass. (Oct 11, 2023) – eGenesis, a biotechnology company developing human-compatible (HuCo™) organs for the treatment of organ failure, today announced publication in the journal Nature of long-term survival data from a proof-of-concept study evaluating engineered porcine donor kidneys transplanted into a cynomolgus macaque model. This dataset will support advancement of the company’s lead candidate for kidney transplant,
EGEN-2784, toward clinical development.

These results represent the largest and most comprehensive preclinical dataset published in the field to date. Recipient survival in the preclinical setting has historically been measured in weeks or months. The publication titled: “Design and Testing of a Humanized Porcine Donor for
Xenotransplantation,” reported long-term survival of NHP recipients of the company’s genetically engineered porcine kidneys. In the case of one recipient, survival of over two years (758 days) was achieved.

“At eGenesis, we are focused on transformational progress for the field – improving long-term survival for transplant recipients from months to years,” said Michael Curtis, Ph.D., Chief Executive Officer of eGenesis. “Our HuCoTM organs offer the hope of a new donor source for the hundreds of thousands of individuals in need of lifesaving organ transplants. The data published in Nature illustrate our rapid advancement in engineering porcine donor organs to enhance recipient compatibility and long-term survival, a critical step toward successful translation in human clinical trials.”

The donor kidneys evaluated in this study carried three types of edits: (1) knock out of three genes involved in the synthesis of glycan antigens implicated in hyperacute rejection, (2) insertion of seven human transgenes involved in the regulation of several pathways that modulate rejection: inflammation, innate immunity, coagulation, and complement, and (3) inactivation of the endogenous retroviruses in the porcine genome.

Donor kidneys carrying human transgenes resulted in longer survival time when transplanted into NHPs. Donor kidneys containing only knock out of the three-glycan antigens experienced poor graft survival, whereas those harboring the knock outs and human transgenes resulted in more than seven times longer duration – a median of 24 days versus 176 days, respectively. The results indicate the benefit of human transgene expression in porcine kidney grafts onlong-term survival.

In vitro functional analysis showed that edited porcine kidney endothelial cells modulated inflammation in a manner that mirrored human endothelial cells, suggesting the edited cells acquired a high level of human immune compatibility. Furthermore, the evaluation of renal function biomarkers in recipients with stable grafts revealed that a single transplanted porcine kidney provided sufficient filtration of metabolites to compensate for the lack of two native kidneys.

“This is a major step forward for the field of transplantation,” said Tatsuo Kawai, M.D., Ph.D., Professor of Surgery at Harvard Medical School and A. Benedict Cosimi Chair in Transplant Surgery at Massachusetts General Hospital. “One of the biggest hurdles has been long-term survival of the genetically engineered organ in the NHP recipient, and this dataset demonstrates remarkable progress in editing the porcine genome to minimize hyperacute rejection, improve recipient compatibility and address the risk of viral transmission from donor to host. We anticipate that transplant outcomes in humans will be even more favorable, as these gene edited organs are a better match for humans, as compared with NHPs.”

The data generated in this study will support the advancement of the company’s lead candidate for kidney transplant, EGEN-2784, toward clinical development. eGenesis is also progressing programs for extracorporeal liver perfusion as well as cardiac transplant.

Organ failure is a life-threatening condition for which transplantation is considered the gold standard treatment. However, the demand for organs far outstrips supply – of the more than 100,000 individuals on the organ transplantation waitlist in the U.S., less than 40% will receive a potentially life-saving organ. In addition, the existing organ failure treatment paradigm is suboptimal for patients and the healthcare system due to organ incompatibility and variable donor organ quality.

Planegg-Martinsried, Germany, 25 September 2023 – 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage CTCL, today announces that renowned dermato-oncology expert and study investigator, Professor Dr. Rudolf Stadler, University Hospital Johannes Wesling, Minden, Germany, presented positive new data from the pivotal RESMAN study of resminostat (Kinselby) at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting, at the Leiden University Medical Center Amsterdam, The Netherlands, 21-23 September.

The presented findings show that maintenance therapy is now clinically proven to postpone disease progression in advanced CTCL which could significantly change clinical practice. In RESMAIN, one of the largest randomized, controlled clinical trials in advanced CTCL, resminostat (Kinselby) treatment has shown a statistically significant improvement in progression free survival of 97.6% compared to placebo, with a risk reduction of 38% in recently announced headline trial results (median PFS: 8.3 months versus 4.2 months; p=0.015; HR: 0.623 (95%CI: 0.424, 0.916).

Furthermore, resminostat (Kinselby)’s median time to next treatment (median TTNT) versus placebo showed a significant improvement of 8.8 months compared to 4.2 months; p= 0.002; HR: 0.594 (95% CI: 0.424, 0.916).

The side effects of resminostat were mainly mild to moderate, manageable and reversible and the known safety profile of resminostat (Kinselby) was confirmed in the RESMAIN study.

Additional analyses established that those treated showed a clinically meaningful improvement in median “total” PFS (defined from start of last prior therapy to disease progression) of 24.3 months, compared to 14.9 months for those in the placebo group. It was also noted that there was a significant delay in the development of new, or worsening of existing, skin tumours.

Jason Loveridge, Ph.D., CEO of 4SC, commented: “Positive data from the RESMAIN study demonstrate that resminostat (Kinselby) is effective in significantly slowing disease progression in CTCL patients. This unique treatment, which is the only proven maintenance therapy for CTCL, means that it is well placed to offer significant benefits for patients who would otherwise have no other similar treatment options available to them. 

Our focus in the near term is on the registration, approval and commercialization of Kinselby in the European Union, Switzerland and the UK and we are on track to file for European Marketing Approval of Kinselby in Q1 2024, to rapidly bring this therapy into clinical use. 4SC is well positioned for realization of resminostat (Kinselby)’s considerable value through either a sale, licensing, or partnership agreement.”

The Company will host a live webinar on Wednesday 4th October to discuss the findings presented at EORTC. Dr. Susanne Danhauser-Riedl, 4SC’s Chief Medical Officer, will be joined by medical experts, Professor Dr. Rudolf Stadler and Professor Julia Scarisbrick, who will provide further detail on these data, with the presentation being followed by the opportunity to ask questions during a Q&A session moderated by Dr. Jason Loveridge, 4SC’s Chief Executive Officer.

Title: Presentation by Professor Rudolf Stadler and Professor Julia Scarisbrick on recent new positive data from the RESMAIN study

Date and Time: Wednesday 4^th October, 3.00pm CET

Register and submit questions: https://stream.brrmedia.co.uk/broadcast/64f5f2dac6e9d7476c27f154

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Cambridge, Massachusetts and Tuebingen, Germany, September 11, 2023 – Moderna, Inc. (NASDAQ: MRNA, “Moderna”) and Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced a strategic research and development collaboration to pioneer novel and transformative therapies for cancer patients with high unmet medical need. This broad multi-platform collaboration will leverage the deep scientific expertise and core operational capabilities of both companies, combining Immatics’ TCR platform with Moderna’s cutting-edge mRNA technology, and span various therapeutic modalities including bispecifics, cell therapy and cancer vaccines.

The strategic R&D collaboration between Moderna and Immatics focuses on three pillars:

• Applying Moderna’s mRNA technology for in vivo expression of Immatics’ next-generation, half-life extended TCR bispecifics (TCER®) targeting cancer-specific HLA-presented peptides.
• Enabling the discovery and development of novel mRNA-based cancer vaccines by leveraging Moderna’s deep knowledge of mRNA science and customized information from Immatics’ wealth of tumor and normal tissue data included in the target discovery platform XPRESIDENT® and its bioinformatics and AI platform XCUBE™.
• Evaluating Immatics’ IMA203 TCR-T therapy targeting PRAME in combination with Moderna’s PRAME mRNA-based cancer vaccine. The collaboration contemplates conducting preclinical studies and a Phase 1 clinical trial evaluating the safety and efficacy of the combination with the objective of further enhancing IMA203 T cell responses.

“We are excited to embark on this strategic collaboration with Immatics, a pioneer in developing innovative cancer immunotherapies. This partnership presents a groundbreaking opportunity to leverage our mRNA technology alongside Immatics’ TCR platform, potentially diversifying and augmenting the way we approach cancer treatment. We believe this collaboration will accelerate the development of novel oncology therapies and bring us one step closer to providing significant benefits for patients with high unmet medical needs,” said Rose Loughlin, Ph.D., Moderna’s Senior Vice President for Research and Early Development.

“We are thrilled to join forces with Moderna in our quest to pioneer innovative and transformative therapies to combat cancer. We believe Immatics’ cancer target and TCR platforms, along with Moderna’s cutting-edge mRNA technology, represent a powerful combination that has the potential to deliver meaningful benefits to cancer patients,” said Toni Weinschenk, PhD, Chief Innovation Officer at Immatics. “The rapid advancement of our first 2 TCER® programs into the clinic, with additional TCER® compounds fueling our pre-clinical pipeline, underscores our commitment to develop innovative therapeutics. We are confident that we can explore the optimal delivery of TCER® molecules through this collaboration to maximize clinical benefit in a broad patient population,” added Carsten Reinhardt, MD, PhD, Chief Development Officer of Immatics.

About the Collaboration
Under the terms of the agreement, Immatics will receive an upfront payment of $120 million. Immatics will also receive research funding and is eligible to receive development, regulatory, and commercial milestone payments that could exceed $1.7 billion. Immatics is also eligible to receive tiered royalties on global net sales of TCER® products and certain vaccine products that are commercialized under the agreement. Under the agreement, Immatics has an option to enter into a global profit and loss share arrangement for the most advanced TCER®.

Moderna will lead the clinical development and commercialization of cancer vaccines and TCER® therapeutics resulting from the collaboration. Immatics will be responsible for conducting the preclinical studies and a potential Phase 1 clinical trial investigating IMA203 TCR-T in combination with the PRAME mRNA vaccine to further enhance IMA203 T cell responses. Each party will retain full ownership of its investigational PRAME compound, and the parties will fund the clinical study on a cost sharing basis.

Within the collaboration, preclinical activities conducted by Immatics will be managed by the Immatics Discovery Unit, a recently created internal division at Immatics integrating its technology platforms into one interdisciplinary team focused on all early-stage preclinical pipeline and collaboration programs.

The collaboration is subject to customary antitrust clearance in the United States.

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Ghent, Belgium – August 29, 2023 – Confo Therapeutics, a leader in the discovery of medicines targeting G-protein coupled receptors (GPCRs), today announced the appointment of Dieter Weinand as Independent Chairman of its Board of Directors. Mr. Weinand brings with him a wealth of experience with more than 35 years in the pharmaceutical industry and over 25 years as the leader of geographic and strategic business units and drug commercialization efforts across global organizations, including several years as the President, CEO and Chairman of the Board of Bayer Pharmaceuticals AG. He joins Confo as the company advances its pipeline and continues to leverage its proprietary GPCR drug discovery engine. Mr. Weinand succeeds John Berriman, who is retiring from his current position as Chairman of Confo’s Board of Directors.

“Dieter is an exceptional leader in the pharmaceutical industry with a proven track record across the spectrum of research and development to commercialization, bringing impactful medications to patients. A chairman of his caliber will be invaluable as we continue progressing as an organization with a truly innovative GPCR-targeting technology and a growing pipeline of novel drug candidates,” said Cedric Ververken, CEO of Confo Therapeutics. “On behalf of the Confo team, I sincerely thank John Berriman for his guidance over the past seven years and his contributions to Confo’s growth into a clinical-stage drug development company.”

“Confo is moving on an exciting trajectory, harnessing the momentum of a pivotal agreement with Eli Lilly for its first clinical program, CFTX-1554, and building out a robust pipeline of large and small molecules based on its unique platform,” added Dieter Weinand, Independent Chairman. “I look forward to working together with the Confo team to advance the company through its next stages of growth and to achieve its future strategic business and pipeline objectives.”

Mr. Weinand has had a highly successful career across all areas of pharmaceutical development, commercialization, and international organizational leadership. Most recently, he was Head of Global Primary Care Business at Sanofi where he led the optimization of the company’s portfolios. Before this, he was President, CEO, and Chairman of the Board of Bayer Pharmaceuticals AG, where he was responsible for integrating the R&D, manufacturing, and all commercial and support functions of the healthcare business of the Bayer AG corporation. Mr. Weinand held various senior management positions across international corporations including at Bristol-Meyers Squibb and Pfizer. He has been instrumental in the launch and marketing of some of the industry’s pivotal products including Lipitor®, Neurontin®, Abilify® and Cipro®. Mr. Weinand holds a B.A. in Biology from Concordia College, New York, and an M.S. in Pharmacology and Toxicology from Long Island University, New York. Mr. Weinand is Chairman of the Board of Nasdaq-listed Replimune (REPL), FORE Biotherapeutics, and ZielBio, among others.

BEVERLY, Massachusetts – August 17, 2023 – Quanta Dialysis Technologies^® today announced that it has completed enrollment of its Home Run study for at-home hemodialysis. The Home Run study is a prospective, multi-center, open-label trial to assess the efficacy and safety of the Quanta Dialysis System for home hemodialysis.  Results are expected to be announced in the second half of 2023.

“People with end-stage kidney disease on hemodialysis are currently limited as to options available.  Although frequent home hemodialysis is proven to deliver superior outcomes, for many, in-center dialysis treatment three times a week is the only viable option,” said Quanta Chief Medical Officer, Dr. Paul Komenda, MHA, FRCPC, FASN.  “We hope that FDA clearance of an additional home hemodialysis device will contribute to more patients having access to regular care in their home environment.   Enrollment completion is the first step forward in a potential new alternative for people with this life-threatening disease.”

Tuebingen, Germany and Houston, Texas, August 10, 2023 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced the initiation of a Phase 1/2 clinical trial with its proprietary Bispecific T cell engaging receptor (TCER®) IMA402. IMA402 is the second product candidate in Immatics’ TCER® pipeline of next-generation, half-life extended bispecific molecules to enter clinical development. It targets an HLA-A*02:01-presented peptide derived from PRAME, a clinically established cancer target frequently expressed in a large variety of solid tumors.

The Phase 1/2 clinical trial (NCT05958121) investigates TCER® IMA402 in HLA-A*02:01-positive patients with PRAME-expressing recurrent and/or refractory solid tumors. The dose escalation part of the study is designed as a basket trial in focus indications to accelerate signal finding. Initial focus indications are cutaneous and uveal melanoma, ovarian cancer, lung cancer, uterine cancer and synovial sarcoma, among others.

“The addition of IMA402 to our clinical pipeline is a truly exciting step and aligns with our strategic goal to harness the full potential of PRAME, one of the most promising cancer targets in solid tumors. With our half-life extended format, we believe IMA402 has the potential to be an attractive treatment option by enhancing efficacy, minimizing toxicities, and providing favorable dosing regimen for cancer patients.,” said Cedrik Britten, Chief Medical Officer at Immatics. “We are working with urgency to bring IMA402 to a broad patient population as quickly as possible and look forward to sharing first clinical data in 2024.”

Primary objectives of the IMA402 Phase 1/2 trial are to determine the maximum tolerated dose (MTD) and/or the recommended doses for trial extensions, as well as to characterize safety and tolerability of IMA402. Secondary objectives are to evaluate anti-tumor activity and assess pharmacokinetics of IMA402. The Phase 1a dose escalation will be followed by a Phase 1b dose expansion, with the plan then to initiate a Phase 2 with indication-specific cohorts and/or combination therapies. Immatics has implemented an adaptive design for the dose escalation with the goal of accelerating the clinical development timeline of IMA402. Pharmacokinetics data will be assessed throughout the trial and might provide an early opportunity for adjustment of the treatment interval based on the half-life extended TCER® format. The trial is initially planned to be conducted at approximately 15 sites in Europe, with extension into the US at dose expansion stage. The Phase 1a is designed to enroll approximately 45 patients.

The trial initiation is based on the comprehensive preclinical studies with IMA402 presented at the European Society for Medical Oncology (ESMO) Congress 2022.

TCER® IMA402 is the second Immatics clinical program targeting PRAME, with the first being ACTengine® IMA203, a TCR-T cell therapy which is currently being evaluated in a Phase 1b dose expansion. Both approaches, ACTengine® and TCER®, are distinct therapeutic modalities that Immatics believes to have the potential to provide innovative treatment options for a variety of cancer patient populations with different medical needs.

Quanta Dialysis System becomes first-in-class to perform three standard-of-care dialysis modalities in one device

BEVERLY, Mass., Aug. 3, 2023 /PRNewswire/ — Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, today announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of the Quanta Dialysis System, a compact and easy-to-use hemodialysis device, for two modalities of continuous renal replacement therapy (CRRT): continuous venovenous hemodialysis (CVVHD) and slow continuous ultrafiltration (SCUF). Under the new 510(k), the Quanta Dialysis System is the only dialysis device FDA-cleared to provide intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED) or bagless CRRT which creates dialysate on demand – all in a single machine.

The Quanta Dialysis System was originally designed to serve the more than two million people with end-stage kidney disease (ESKD) worldwide who receive treatment with dialysis or a kidney transplant. The latest addition of its Trinal Kidney Therapy™ (TKT) software provides a treatment solution for critically ill patients diagnosed with acute kidney injury (AKI) who require dialysis. It features dialysate flow rates from 50 to 500 mL/min and treatment times up to 24 hours of continuous delivery.

“This clearance is a true game-changer for acute care settings,” said Quanta Chief Executive Officer, Alejandro Galindo. “Hospitals are often constrained with limited space and nursing staff. The Quanta Dialysis System with TKT software provides an all-in-one solution for hospitals with an intensive care unit (ICU) looking to reduce their device footprint, maximize their operational efficiencies, reduce burden on nurses and substantially lower consumables expenses.”

Mortality for ICU patients with severe AKI who need dialysis has been reported to exceed 50% in patients often requiring intravenous life support to maintain a minimum blood pressure. CRRT offers a slower and gentler alternative to conventional dialysis; continuous dialysis runs 24 hours a day as compared to traditional hemodialysis which occurs over a four-hour period enabling better real time management of volume and biochemistry for patients.

“Critically ill patients that are hemodynamically unstable, such as those with severe AKI, are more challenging to manage in the ICU balancing volume status, inotropic support and ventilation requirements. Because of its slower rate of fluid removal, CRRT may cause less stress for the patient and enable more real-time decision making for clinical teams on a minute-to-minute basis,” said Quanta Chief Medical Officer, Dr. Paul Komenda, MHA, FRCPC, FASN. “However, once the hemodynamic status of the patient has improved, a transition to IHD or SLED may be the best option. A device than can perform all three modalities in one is ideal.”

Quanta is ready to commercialize the Quanta Dialysis System with TKT software and expects to officially launch the product at the 2023 American Society of Nephrology Annual Meeting.