Sealonix Files for IPO: Innovative Hemostatic Sealant PramStat Reduces Bleeding Time by Average of 16 Minutes

Rapid hemostatic sealants can save patients’ lives by preventing shock and death due to excessive blood loss from severe trauma or surgical wounds. Ideal hemostatic sealants, achieved through precise chemical modifications or specific morphological designs, not only effectively control bleeding immediately but also exhibit excellent biocompatibility and biodegradability, making them widely applicable to various wound scenarios.

To develop a truly ideal hemostatic sealant, breakthroughs are required across multiple dimensions—including safety, efficacy, ease of use, cost control, and regulatory compliance—while continuously addressing emerging challenges.

Based on this, Sealonix was officially founded in January 2023, dedicated to leveraging its unique biomaterials technology to develop and commercialize high-performance hemostatic sealant products, bringing innovative hemostatic solutions to the global medical field.

May 2023,Sealonix, Established Just Four Months Ago, Officially Announces Completion of $20 Million Series A Financing Round. This financing round was led by Excelestar Ventures, with active participation from several top-tier investment firms, including AMED Ventures, Sparta Group, Iyengar Capital, J2 Ventures, and TiE Boston.

This capital injection has undoubtedly injected strong momentum into Sealonix’s future development, particularly in driving itsClinical Development and Application of the Next-Generation Hemostatic Sealant PramStat。

Sealonix was founded by serial entrepreneur Dr. Amar Sawhney. Over the course of several decades, Dr. Sawhney has not only successfully established well-known companies such as Confluence Surgical (later acquired by Tyco International), Ocular Therapeutix (which completed a successful IPO), and Augmenix (acquired by Boston Scientific), but also spearheaded the creation of multiple innovative ventures, including Instylla, Pramand, and Rejoni.

To further expand its business landscape,Dr. Amar Sawhney, together with Professor William Spotnitz of the Department of Surgery at the University of Virginia Health System, jointly entering the field of hemostatic sealants. It is reported that Professor William Spotnitz has over 20 years of research and clinical experience in the field of cardiothoracic surgical techniques.

In complex cardiothoracic surgeries, the risk of bleeding remains a critical concern that cannot be overlooked. In clinical practice, the use of anticoagulants, the establishment of cardiopulmonary bypass circuits, and patients’ underlying pathological factors can all exacerbate the risk of hemorrhage. The combined effect of these factors can lead to impairment of the coagulation cascade, activation of the fibrinolytic cascade, decreased platelet function, intensified inflammatory responses, and hemodilution, potentially even causing acidosis and hypothermia, thereby creating a substrate for coagulopathy.

As early as 1999, Professor William Spotnitz evaluated the efficacy of fibrin sealant in preventing bleeding following a 15-gauge needle biopsy in a canine model with simulated heparinized coagulopathy. Using the same sheath system employed for obtaining biopsy specimens, fibrin sealant was delivered to the biopsy tract sites in eight heparin-anticoagulated dogs (activated clotting time 387 ± 94 seconds).

Experimental results demonstrated that, compared with the control group, complete hemostasis was achieved in the tracts occluded by the sealant. No persistent bleeding was observed at any fibrin sealant–treated sites, whereas it occurred at all control biopsy sites (P = 0.0078). These findings indicate the high efficacy of fibrin sealant, delivered via a sheath system, in occluding liver biopsy tracts and eliminating bleeding in an animal model with severe coagulopathy.

Subsequently, building on his research into fibrin sealants, Professor William Spotnitz developed a novel combination powder hemostatic agent that enables collagen to activate platelets, chondroitin sulfate to adhere the wound to surrounding tissues, and thrombin to convert fibrinogen into fibrin.

This new hemostatic agent has also become Sealonix’s star product—PramStat Sealant Patch: Designed for Abdominal and Orthopedic Surgeries, Absorbed by the Body Within One Week After Implantation。

Sealonix officially disclosed,The core of the PramStat patch lies in its unique Combination Powder (CP) technology, which consists of three biomaterials: porcine collagen, bovine chondroitin sulfate, and human plasma thrombin, each playing a critical role.。

Porcine collagen was selected for its excellent biocompatibility and ability to promote platelet activation, enabling it to rapidly form a protective matrix at the wound site and facilitate the coagulation response. Bovine chondroitin sulfate is known for its properties in enhancing tissue adhesion and promoting wound healing, which helps ensure tight integration of the patch with the surrounding tissue and reduces the risk of bleeding. Finally, human mixed plasma thrombin is a key enzyme in the hemostatic process; it converts fibrinogen into fibrin, thereby accelerating clot formation and achieving effective hemostasis.

The PramStat patch is designed to be gradually bioabsorbed by the body within one week after implantation. This feature eliminates the need for additional surgical procedures to remove the patch, thereby reducing patient discomfort and the risk of complications during treatment. Furthermore, the biodegradability of the patch ensures that it gradually degrades during the wound healing process, providing space for the growth of new tissue.

To scientifically validate the clinical efficacy of the novel hemostatic agent, Sealonix conducted a rigorous clinical study comparing the performance of CP Hemostat with other hemostatic agents in cardiothoracic surgery. The study employed a linear regression model to retrospectively evaluate postoperative data from a total of 162 patients across two groups. Parameters assessed included blood loss, protamine-to-skin closure time, chest tube output at 48 hours postoperatively, blood product requirements, ICU length of stay, incidence of postoperative complications, and 30-day mortality.

The research results show that,In complex cardiothoracic surgeries, patients treated with the CP hemostatic agent demonstrated significantly better outcomes than the control group in terms of blood loss (mean reduction: 886.51 mL, P=0.003), hemostasis time (mean reduction: 16.81 minutes, P=0.004), chest tube output (mean reduction: 445.76 mL, P<0.001), red blood cell transfusion requirements (mean reduction: 0.98 units, P=0.001), and postoperative complications (mean reduction: 0.31, P=0.012).。

“CP hemostatic agent can more effectively control bleeding, reduce blood loss and transfusion requirements, while shortening operating room time and lowering the incidence of postoperative complications and 30-day mortality,” Professor William Spotnitz stated publicly.

May 2023,Tasneem Dohadwala, Founding Partner of Excelestar Ventures, Joins Sealonix’s Board of DirectorsDr. Tasneem Dohadwala has accumulated decades of experience in financial services at Lehman Brothers and Matrix Partners. As an investor, she has also invested in multiple innovative companies, including Augmenix, nVision, Conformal Medical, Diesel Labs, Instylla, and Altiostar Networks. It is understood that Dr. Dohadwala’s addition will also facilitate Sealonix’s next round of financing and the clinical trials of its projects.

Meanwhile, research on hemostatic agents in China has continued. In 2019, a research team led by Professor Wu Decheng from the Institute of Chemistry, Chinese Academy of Sciences, and a team led by Professor Tang Peifu, Director of the Department of Orthopedics at the Chinese PLA General Hospital, jointly developed a four-arm polyethylene glycol medical sealant (SS) based on a succinyl ester structure.

It is understood that the SS sealant achieves cyclization of succinyl esters through an intramolecular nucleophilic substitution mechanism, thereby enabling a rapid and controllable degradation process. This characteristic allows the SS sealant to be rapidly absorbed or cleared by the body after hemostasis is achieved, reducing the risk of foreign body reactions and promoting faster wound healing.

In experiments, the SS sealant not only demonstrated excellent performance in cysteamine solution, achieving complete dissolution within 30 minutes, but also allowed for easy removal of residues from tissue pores when wiped with a swab soaked in the removal solution. Furthermore, subcutaneous and intramuscular implantation studies confirmed that the SS sealant exhibits superior biocompatibility, without inducing long-term foreign body reactions or adverse effects.

However, overall, the market for absorbable hemostatic materials in China started relatively late. Currently, the market is valued at tens of billions of yuan, with imported products having long held a dominant position.. For example, in the field of absorbable hemostatic fluid gelatin, there were no breakthroughs for nine years after the first U.S.-funded product received approval in 2014. It was not until 2023 that the “Absorbable Hemostatic Fluid Gelatin,” independently developed by Jiangxi Born Real Biotechnology Co., Ltd., an enterprise based in the Xiaolan Economic and Technological Development Zone, was approved by the National Medical Products Administration and officially launched on the market.

For companies, hemostatic materials are characterized by “low risk and high returns,” a feature that is attracting numerous new market entrants.