Enzymatica and STADA sign partnership agreement for Germany and Austria

 

• The new partnership agreement covers the launch and distribution of Enzymatica’s ColdZyme® technology in oral spray form in Germany and Austria
• The partnership combines Enzymatica’s clinically documented medical device with STADA’s comprehensive commercial platform
• The commercial impact is expected to be realized progressively from the 2026/2027 cold and flu season, when STADA will market the product under its own brand names.

Enzymatica AB (publ) and STADA Arzneimittel AG have entered into a partnership agreement regarding the launch and distribution of Enzymatica’s ColdZyme® oral-spray technology in Germany and Austria. The commercial impact is expected to be realized progressively starting from the 2026-2027 colds and flu season.

The new agreement builds on prior experience and collaboration between the two companies in Germany and Austria and combines Enzymatica’s clinically documented medical device with STADA’s comprehensive commercial platform.

Strong commercial platform for long-term growth
As part of the amended partnership, STADA will conduct a structured, comprehensive launch of the oral spray in Germany and Austria, where the product will be marketed under STADA’s own brand names. The initiative will be integrated into STADA’s established commercial platform within the group’s Consumer Healthcare segment and will include targeted activities across both pharmacies and digital channels, with a clear focus on the product’s clinical evidence and its unique, differentiated positioning in the category.

As a top five player in Consumer Healthcare in Europe, STADA holds a leading position in Germany, especially in the cough/cold and respiratory market sector. The group intends to use its extensive pharmacy distribution and salesforce, deep consumer insights and 130-year heritage to establish its brands and create long-term value.

“This is a significant breakthrough for Enzymatica. Germany is the largest and most important cold and flu market in Europe. Entering into a partnership with STADA confirms ColdZyme’s competitiveness and commercial relevance. With the right partner in place, we can build long-term and create the conditions for significant volumes over time,” says Sana Alajmovic, CEO of Enzymatica.

“We see the ColdZyme medical-device technology as a strong and clinically differentiated addition to our cold and flu portfolio,” comments Volker Sydow, STADA’s Head and EVP of Global Consumer Healthcare. “With our established pharmacy platform and an integrated marketing strategy, we see attractive opportunities to create long-term value for our retail and commercial partners in the German and Austrian markets.”

Gradual scale-up with clear impact from 2027
Calendar year 2026 will be characterized by preparations, marketing activities, and initial deliveries into Germany and Austria. The more substantial commercial impact is expected to be realized progressively from the 2027 colds and flu season, when the initiative will be fully integrated into STADA’s Consumer Healthcare marketing and campaign structure. 

GCE MEDICAL PORTFOLIO EXPANDS MDR CERTIFICATIONS, REINFORCING SAFETY AND COMPLIANCE ACROSS HEALTHCARE DEVICES

  GCE® Medical, a global leader in medical gas equipment and respiratory care technology, has expanded European Union Medical Device Regulation (MDR) certification across numerous products within its healthcare portfolio. This milestone reinforces the company’s commitment to meeting the highest standards of safety, performance, and clinical efficacy for medical devices supplied throughout the European Union and global markets.

 

“The additional MDR criterion is critical for healthcare providers and distributors operating in regulated markets,” says Ivan Whelan, Global QA/RA Director. “Our commitment to meeting these criteria provides peace of mind for multinational companies. No matter where they operate, healthcare companies can be assured GCE products comply with MDR requirements.”

 

The MDR framework, established under Regulation (EU) 2017/745, replaced the previous Medical Device Directive (MDD) as of May 26, 2021. It introduced a more rigorous compliance regime, requiring manufacturers to demonstrate comprehensive safety, clinical evaluation, and post-market surveillance for medical devices placed on the European market.

 

Zen-O™: Portable Oxygen Therapy Aligned with MDR Requirements

GCE’s expanded MDR coverage includes portable oxygen therapy solutions from its Zen‑O™ line, a key platform supporting long-term oxygen therapy in homecare settings. The devices provide both pulse-dose and continuous-flow oxygen delivery, incorporating adaptive oxygen delivery technology intended to respond to patients’ breathing patterns across varying activity levels. The new certification requires compliance with significantly higher standards for clinical evaluation, risk management, technical documentation, labeling, and post-market surveillance compared to the former certifications and directives.

 

Strengthening Regulatory Readiness Across Medical Gas Systems

In addition to Zen-O, GCE’s MDR-certified portfolio spans medical gas control and delivery components used across hospital and homecare environments. This demonstrates GCE’s broader regulatory strategy to anticipate essential respiratory and gas management technologies under the MDR framework.

About GCE Medical

GCE Medical is the healthcare division of Gas Control Equipment (GCE), part of the ESAB Corporation. With over a century of experience in gas control manufacturing, GCE products are used in medical facilities worldwide. Its wide portfolio supports care across all settings, such as homecare, emergency response, hospitals, and central gas systems, positioning GCE Medical as a complete, end-to-end solution provider. For more information, visit https://www.gce-medical.com/

New treatment for blood cancer using homegrown CAR-T therapy showing strong outcomes in first patients

 

Doctors at Rabin Medical Center have successfully produced genetically engineered cellular therapy, suitable even for patients with treatment-resistant disease. Recently, the first three myeloma patients were successfully treated at Davidoff Cancer Center. Prof Gal Markel: “Soon, we will harness the advanced therapeutic developments to target solid tumors such as lung and liver cancer, and later, autoimmune diseases".

 

  A major medical breakthrough has taken place at the Davidoff Cancer Center at Rabin Medical Center. In the laboratories of the Samueli Integrative Cancer Pioneering Institute, scientists have begun in-house production of genetically engineered cell therapies based on CAR-T (Chimeric Antigen Receptor) technology, designed also for multiple myeloma patients whose disease is resistant to several lines of treatment.

 

The first three patients underwent the procedure without any unusual complications and were discharged home as planned. CAR-T technology represents one of the most advanced innovations in modern cancer care. Immune system cells (T-cells) are taken from the patient and genetically engineered in the lab so they can identify and destroy myeloma cells. The retroviral vector technology to equip T-cells with myeloma-targeting CARs was developed in the labs of Dr. Armin Rehm and Dr. Uta Höpken at the Max Delbrück Center in Berlin, Germany. The engineered cells are then reinfused into the patient’s body, where they attack the cancer.

 

Each year in Israel, about 550 new patients are diagnosed with multiple myeloma, a cancer of the bone marrow. While treatment options and life expectancy have improved significantly, some patients do not respond to existing therapies, making advanced treatments urgently needed. 

                                           

 

The Samueli Integrative Cancer Pioneering Institute, led by Avner Paz-Tsuk, was established in 2023 and operates under the highest international standards for advanced therapy production. Its work is integrated within the Hemato-Oncology Division, headed by Prof. Pia Raanani. The CAR-T program is led by Prof. Michal Besser, Chief Technology Officer at Samueli Institute & the Davidoff Cancer Center. The clinical study is directed by Prof. Moshe Yeshurun, Head of the Bone Marrow Transplant Unit, in collaboration with Dr. Iuliana Vaxman, Head of the Center for Multiple Myeloma and Rare Plasma Cell Disorders, and with Prof. Salomon Stemmer, Deputy Director of the Davidoff Center and Co-Founder of the Samueli Institute. The retroviral vector that delivers the gene encoding the engineered CAR into cells was provided by researchers at the Max Delbrück Center.

 

Dr. Iuliana Vaxman, Head of the Center for Multiple Myeloma and Rare Plasma Cell Disorders at the Davidoff Cancer Center, Rabin Medical Center: "Within our Hematology Division, we established a dedicated center for multiple myeloma and rare plasma cell diseases. As part of a clinical study, we began administering this treatment, and the early results show a very positive response. This is significant news for these patients. Our goal is to provide comprehensive care within the new center, and the availability of this innovative, locally produced technology at RMC will allow us to achieve that.”

 

Prof. Gal Markel, Director of the Davidoff Cancer Center at Rabin Medical Center: "In a short time, we have established advanced capabilities for developing and manufacturing original therapies using cutting-edge technologies. Combined with our clinical expertise, this positions Rabin Medical Center as a leader in advanced cancer treatment. This remarkable achievement belongs to the Samueli Institute and the dedicated teams of the Davidoff Hematology Division, who worked in full synergy- from production to patient care. Soon, we will expand CAR-T development and treatment to include solid tumors such as liver and lung cancer, and later autoimmune diseases, all produced and administered right here under one roof.”    

 

Video>>

https://drive.google.com/file/d/1bUFJVPvAShuY5XMOdhqRe5xPg987MC7T/view?usp=sharing

 

 

One in a Million: Two twins out of triplets underwent a life-saving in-utero operation

 

A very rare coincidence at Rabin Medical Center - Beilinson Hospital in Israel: a triplet pregnancy with a life-threatening and extremely rare blood-flow complication ended with a successful cesarean delivery. At 26 weeks of pregnancy, two of the three fetuses underwent a complex, life-saving fetal surgery. Remarkably, this is the second time in the same family that twins with the same complication have undergone the exact same procedure.

Avishag Davidov, a 27-year-old makeup artist, and her husband Michael, 34, were surprised to discover that she was carrying a unique triplet pregnancy: a girl and two identical boys sharing one placenta. During the pregnancy, the boys were diagnosed with Twin-to-Twin Transfusion Syndrome (TTTS), a condition that endangered their lives. They were saved through a rare and complex in-utero laser surgery to separate the blood vessels connecting the twins. The procedure was performed by Dr. Yuval Gielchinsky, a fetal medicine specialist and Director of the Fetal Medicine Unit at Rabin Medical Center, and Dr. Kinneret Tenenbaum-Gavish, Head of the Twin Clinic. 

                                     

In Avishag’s family, this was not the first intrauterine surgery. Twenty years ago, her mother Ilana was pregnant with identical twins (Avishag’s brothers) who also developed TTTS, and she underwent the procedure in Belgium.

“TTTS is a dangerous complication that can occur in identical twins sharing a single placenta. In this condition, their blood vessels are connected within the placenta, and one fetus transfers blood to the other. They share a common circulatory system, which leads to an imbalance - one fetus receives too much blood while the other receives too little,” explains Dr. Gielchinsky, who performed the surgery on Avishag. 

                        

During the procedure, a thin camera and a laser fiber are inserted through the abdominal wall into the amniotic sac, and the connecting blood vessels between the twins’ circulatory systems are sealed. In the case of triplets, the surgery is significantly more complex due to the limited access to the uterus and the need to protect the third fetus.

“The syndrome develops in about 20% of identical twin pregnancies and can worsen rapidly, threatening the fetuses’ lives within days or weeks. Therefore, women carrying such pregnancies must be monitored every two weeks at a specialized identical-twin clinic, such as the one we have at Rabin Medical Center’s Fetal Medicine Unit.”

The triplets are now in good condition and, following delivery, received care at a neonatal intensive care unit.