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Delray Beach, FL, and Enschede, Netherlands, March 18, 2025 – Cyrano Therapeutics, a clinical-stage regenerative medicine company pioneering the development of treatments for smell loss, and Resyca, a leading innovator in soft mist inhaler and soft nasal spray technologies, today announced they have entered into an exclusive licensing agreement for Resyca’s proprietary soft mist nasal spray technology for the treatment of chemosensory disorders, including post-viral smell loss (hyposmia).

This agreement marks a major milestone in advancing an innovative treatment to address this critical unmet medical need. Cyrano Therapeutics’ lead therapy, CYR-064, has progressed its Phase 2 FLAVOR clinical study utilizing Resyca’s soft mist nasal spray technology, with top-line data expected in the second half of 2025.

Resyca’s proprietary soft mist nasal spray technology is designed to optimize drug deposition in the nasal cavity and the olfactory region. Specific to CYR-064, the precisely controlled droplet size and low spray velocity has the potential to improve drug distribution to the target olfactory region, thereby increasing the opportunity for therapeutic efficacy. Integrated into Ursatec’s spray pump system, Resyca’s soft mist technology offers a patient-friendly design that supports safe and effective administration, making it particularly well-suited for treating persistent smell loss.

“This agreement with Resyca enables us to enhance the efficacy of our treatment for patients experiencing chemosensory dysfunction by delivering our proprietary formulation through their advanced soft mist technology,” said Rick Geoffrion, CEO of Cyrano Therapeutics. “Resyca’s soft mist technology plays a critical role in optimizing the deposition and delivery of CYR-064 in the olfactory region to maximize its therapeutic potential. This advanced delivery system has been integral to our Phase 2 FLAVOR trial, which is currently wrapping up enrollment.”

Remko Beimers, CEO of Resyca, added, “Our patented soft mist nasal  technology enables advanced drug delivery for both biologics and small molecules. Partnering with Cyrano Therapeutics aligns with our mission to drive innovation in drug delivery solutions. We believe this collaboration will help patients regain their sense of smell, achieve better treatment outcomes, and create a barrier to entry for any future competitors.”

As the development of Cyrano Therapeutics’ product CYR-064 progresses toward commercialization, Cyrano Therapeutics and Resyca are committed to bringing this innovative treatment to patients with chemosensory disorders. This partnership underscores their shared dedication to scientific innovation, patient-focused drug delivery, and advancing therapeutic solutions for smell loss.

Hyposmia, including post-viral hyposmia, is an increasingly prevalent and serious chronic sensory condition for which there is no approved drug therapy and limited treatment options. Hyposmia causes significant impairment in quality of life for many sufferers. Moreover, in older individuals, hyposmia is associated with an increased risk of cognitive impairment and mortality. There is currently no FDA-approved therapy indicated for the treatment of smell loss.

About Cyrano Therapeutics

Cyrano Therapeutics is a private, venture-backed clinical stage regenerative medicine company. Since our foundation, we have been working diligently to develop therapies for people struggling with the loss of smell and taste.

More information: cyranotherapeutics.com

About Resyca®

Resyca® was founded in 2020 and is a joint venture between Bespak and Medspray. Resyca® specialises in the development and manufacturing of compact, user-friendly soft mist inhalation and soft nasal spray devices, incorporating the proprietary Medspray micro-nozzle technology. These devices are tailored for pulmonary and nasal applications, utilising standard pre-filled syringes / primary packaging and filling lines. As the soft mist development centre within Bespak, Resyca offers comprehensive services spanning from early-stage development through to commercial production, inclusive of filling, labelling, and packaging.

For further information and interview opportunities with Resyca®, please contact:

Bernhard Müllinger at Resyca BV
Email: info@resyca.com
Website: www.resyca.com

The post Cyrano Therapeutics and Resyca announce exclusive license agreement for soft mist nasal spray technology for the treatment of persistent smell loss first appeared on Resyca.

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Enschede, Netherlands, January 28, 2025 – Resyca BV, a pioneering leader in the development and manufacturing of advanced inhalation drug delivery devices, proudly announces successful certification under the European Medical Device Regulation (MDR, Regulation (EU) 2017/745) by notified body TÜV SÜD Product Service. This certification marks a significant milestone, demonstrating that all Resyca’s design, development, and manufacturing processes comply fully with stringent MDR requirements.

With MDR certification, Resyca is strategically positioned to support its pharmaceutical partners in navigating the complex European regulatory landscape for Medical Devices and Drug-Device Combination (DDC) products. The certification ensures that Resyca’s devices meet the highest safety and performance standards, significantly streamlining the EU submission process for combination products. Pharmaceutical partners can leverage this certification to accelerate market access for their inhalation therapies, reducing regulatory hurdles and ensuring EU compliance.

“This achievement is a testament to the dedication and expertise of our team,” said Bernhard Müllinger, Chief Operating Officer at Resyca BV. “The MDR certification underscores our commitment to delivering high quality, patient-centric inhalation drug delivery solutions. It also strengthens our position as a trusted partner for pharmaceutical companies seeking to bring innovative therapies to market efficiently and compliantly.”

The certification by TÜV SÜD Product Service confirms that Resyca has implemented a robust quality management system that aligns with the latest EU regulatory standards, ensuring the safety, performance, and reliability of its inhalation devices. By achieving this milestone, Resyca continues to demonstrate leadership in the evolving landscape of inhalation drug delivery, offering cutting-edge solutions that meet the needs of both patients and pharmaceutical partners.

About Bespak

Bespak® is a global contract development and manufacturing organisation (CDMO) focused on inhaled and nasal drug delivery devices and drug-device combination products. Bespak develops and manufactures finished pharmaceutical products, as well as being a leading global supplier of drug delivery devices and componentry to the pharmaceutical industry. With a long history in the development and commercial supply of pressurised Metered Dose Inhalers (pMDIs), Bespak supplies a major proportion of the world’s pMDI dosing valves and actuators, and also specialises in the industrialisation and high-volume manufacture of complex dry powder inhaler (DPI) devices.  Headquartered in Holmes Chapel, UK, the company’s service offering spans early-stage feasibility, analytical services and product development, from pilot-scale, through to clinical supply and commercial-scale drug product fill-finish, device and component manufacturing.

More information: www.bespak.com

About Medspray

Medspray is a privately owned company in Enschede, the Netherlands. With its 40 employees, Medspray focuses on the development and manufacturing of micro spray nozzles which are able to deliver soft mists. Medspray’s slogan is: “tiny technology for a sustainable future.” Medspray aims to contribute to a sustainable world by developing innovative spray nozzles for user-friendly health and personal care products, where a slow-moving soft spray is required , and without the use of propellants.  Thanks to the high-tech nozzle chips, sprays can be tailored to suit any application, from inhalable aerosol clouds, to gentle nasal sprays, to cosmetic or fragrance sprays that do not feel wet on the skin.

More information: www.medspray.com

About Resyca®

Resyca® was founded in 2020 and is a joint venture between Bespak and Medspray. Resyca® specialises in the development and manufacturing of compact, user-friendly soft mist inhalation and soft nasal spray devices, incorporating the proprietary Medspray micro-nozzle technology. These devices are tailored for pulmonary and nasal applications, utilising standard pre-filled syringes / primary packaging and filling lines. As the soft mist development centre within Bespak, Resyca offers comprehensive services spanning from early-stage development through to commercial production, inclusive of filling, labelling, and packaging.

For further information and interview opportunities with Resyca®, please contact:

Bernhard Müllinger at Resyca BV
Email: info@resyca.com
Website: www.resyca.com

The post Resyca receives medical device regulation certificate from TÜV SÜD first appeared on Resyca.

SARASOTA, FL, July 18, 2024 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced it has entered into a Device and CMC Development Master Plan with Resyca BV, a medical technology provider. Resyca is a joint venture between Bespak Group and Medspray Pharma BV which manufactures the formulation-specific microchip-based spray system chosen by Silo for its lead candidate SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).

“The patented nasal spray system uses cutting-edge nose-to-brain drug dispersion, a delivery method that transports the molecules to the brain directly, bypassing the blood-brain barrier,” said Eric Weisblum, Chief Executive Officer of Silo Pharma. “For SPC-15, we believe this delivery method could increase the drug’s concentration in the brain to deliver a faster onset of therapeutic benefit and optimized safety for PTSD patients.”

This Device and CMC Development Master Plan is intended to support the development, clinical formulation, and stability of a previously announced investigational new drug (IND)-enabling, large animal GLP (Good Laboratory Practice) study of SPC-15. As part of an existing exclusive license agreement with Medspray Pharma BV, one of joint venture members of Resyca BV, Silo holds exclusive rights to Medspray’s spray mist technology for use with multiple indications including PTSD.
Silo is currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic studies and recently submitted a pre-IND briefing package and meeting request to the U.S. Food and Drug Administration (FDA) for SPC-15. The studies are the final steps required before submission of an IND application to the FDA with the goal of starting its first in human clinical trial.

About SPC-15

SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist that utilizes biomarkers for the treatment of PTSD, anxiety, and other stress-induced affective disorders. SPC-15 is being developed as an intranasal medication. If clinically successful, SPC-15 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Silo Pharma is conducting preclinical studies of SPC-15 in collaboration with Columbia University and was granted an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.

About Silo Pharma

Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug delivery systems. The Company’s lead program, SPC-15, is an intranasal treatment targeting PTSD and stress-induced anxiety disorders. SP-26 is a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo’s two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (MS). Silo’s research and development programs are conducted through collaborations with Columbia University and the University of Maryland, Baltimore. For more information, visit www.silopharma.com and connect on social media at LinkedIn , X , and Facebook .

About Resyca®

Resyca® was founded in 2020 and is a joint venture between Bespak and Medspray. Resyca® specialises in the development and manufacturing of compact, user-friendly soft mist inhalation and soft nasal spray devices, incorporating the proprietary Medspray micro-nozzle technology. These devices are tailored for pulmonary and nasal applications, utilising standard pre-filled syringes / primary packaging and filling lines. As the soft mist development centre within Bespak, Resyca offers comprehensive services spanning from early-stage development through to commercial production, inclusive of filling, labelling, and packaging.

For further information and interview opportunities with Resyca®, please contact:

Bernhard Müllinger at Resyca BV
Email: info@resyca.com
Website: www.resyca.com

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors.

Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.

The post Silo Pharma and Resyca BV partner on device and CMC development for intranasal PTSD drug SPC-15 first appeared on Resyca.