The clinical data of the first domestic minimally invasive application hemostatic gel disclosed that the standard imported products will soon break the monopoly
As a must-have in difficult surgery, hemostatic fluid products are widely used in minimally invasive surgery, brain surgery, spine surgery and other surgeries. In this segment of the segment where imported products dominate, imported hemostatic fluids have established an annual sales scale of hundreds of millions of dollars.
"The introduction of imported hemostatic fluids provides an excellent solution for clinical surgical hemostasis, but the domestic clinical terminal price is between 3000-3500 yuan / stick, and as an imported product, it is often not reimbursable or the reimbursement ratio is very low, causing a heavy economic burden to patients." Dr. Huanan Wang, founder of Huanuo Biotech, told Arterial Network.
Under the background of the increasing volume of surgical procedures in China year by year and the rapid rise of minimally invasive surgery, the clinical demand for domestic cost-effective and minimally invasive high-end hemostasis consumables has become particularly urgent.
Recently, Huanuo Bio announced the interim clinical trial data of the self-developed absorbable hemostatic gel product "Cocoagulant Colloidose", which is the first domestic minimally invasive application of hemostatic gel consumables, with excellent injectable and plasticizable properties, completely degradable absorption in vivo, a wide range of application departments, can be perfectly attached to the bleeding wound to achieve hemostasis, and its sub-micron scale microstructure is more conducive to activating its own coagulation reaction to accelerate hemostasis, excellent hemostasis effect, with biocompatibility and biosecurity and other advantages.
Comparison of clinical human trial data from the current stage of coagulation Colloidose hemostatic gel (experimental group) and imported hemostatic fluid (control group) (*stands for p
Clinical trials have shown that in gynecological surgery, The average hemostatic time of the coagulation Colloidose hemostatic gel (experimental group) was 42.5s, and the average hemostasis time of the imported hemostatic fluid (control group) was 53.1s; in the orthopedic surgery, the average hemostasis time of the coagulation Colloidose hemostatic gel was 30.5s, and the average hemostatic time of the imported hemostatic fluid was 35.7s; in the general surgery, the average hemostasis time of the coagulation Colloidose hemostatic gel was 33.2s, the average hemostasis time of the imported hemostatic fluid was 43.5s, and the general hemostasis time of the coagulation Colloidoid hemostatic gel was significantly shorter than that of imported products (p
It can be seen that Colation Colloidose has a good performance in the key data of effective hemostasis time, and the comprehensive cost performance is extremely high, which will bring subversive innovation to China's high-end trauma hemostasis market.
Average effective hemostasis time,
Security is effectively improved
According to Frost & Sullivan, the number of surgical units in China was 60.43 million units in 2018, with a compound annual growth rate of 8.4% during the period, and an estimated compound annual growth rate of 8.0%, reaching 88.8 million units in 2023 and 152 million units in 2030.
The steady growth in the number of surgical procedures has led to a simultaneous increase in hemostatic products that are indispensable for surgery. Domestic biomedical hemostasis products with an annual growth rate of 22.5% rapid expansion, but including hemostatic gauze, hemostatic sponge, hemostatic membrane and other low-end consumables, although occupying 78% of the entire hemostasis consumables market share, but more for the treatment of open surgery bleeding, need to combine the doctor's long-term physical compression, and only for wound rules, small bleeding bleeding scenarios.
Moreover, the production and manufacturing process of hemostatic gauze and hemostatic sponge low-end consumables raw materials is relatively simple, the added value is low, and there are technical bottlenecks in the compression of tissue after water absorption and expansion at the trauma site, incomplete wound surface closure, easy bleeding, and difficult to control degradation.
With the acceleration of minimally invasive and refined surgery to replace traditional open surgery, the demand for high-end hemostasis consumables has increased rapidly. According to the data in 2018, the proportion of minimally invasive surgery in most ordinary tertiary hospitals in China is close to 30% of the total number of surgical operations, and the proportion of cardiovascular, orthopedic, gynecological and general surgery is higher.
For high-tech and high-precision surgery such as minimally invasive surgery, brain surgery and spine surgery, the traditional block and pre-formed hemostasis consumables can not be carried out to meet the needs, and it is necessary to choose high-end new hemostasis consumables that can be injected by endoscopy, cured and shaped after injection, degradable absorption, no volume expansion after blood sucking, and better biocompatibility. Hemostatic fluids are representative products.
Imported hemostatic fluid can be injected through a minimally invasive catheter, although it is conducive to covering the bleeding wound, but the viscosity is low, it cannot be cured after injection, and it is impossible to meet the hemostasis of the wound with large bleeding flow, and it is often washed away by the blood flow during the operation, and the hemostasis fails. However, for wounds with little bleeding, physical barrier or closure of the bleeding site can be achieved to a certain extent, and it can be degraded and absorbed, so it has a certain degree of clinical recognition.
The hemostatic gel developed by Huanuo Biotech using a new generation of self-healing material technology has brought a glimmer of light to China's breakthrough in the monopoly of imports of high-end hemostasis consumables and improve the effect of high-precision surgical hemostasis.
Huanuo Bio's absorbable hemostatic gel coagulation Colloidose is based on the self-assembly of gelatin submicron particles, with excellent injectability and plasticity, which can be directly implemented in the abdominal organ hemorrhage hemostasis through laparoscopic surgical catheters, and can be degraded and absorbed after implantation, filling the gap of domestic injectable and plastic hemostasis consumables.
In large animal hemostasis tests and clinical human trials, Cocoagulant Colloidose was significantly better than imported hemostatic fluids in terms of two key indicators of average effective hemostasis time and material degradation.
Data on the effective hemostasis time of animal experiments with coagulation Colloidose hemostatic gel (experimental group) and imported hemostatic fluid (control group) (blank group without application of any treatment)
Experimental data based on liver bleeding model of large animal pigs showed that the average effective hemostasis time of Coloidose was 87s, which was significantly lower than the average effective hemostasis time of imported hemostasis of 114s. In the analysis of wound healing and implant degradation at the liver implant site, it was found that the wounds using coagulation Colloidose and imported hemostatic fluids to stop bleeding healed well within 4 weeks, and no material residue was observed in the Warner product group, while some animals in the imported product group still saw material residue at 4 weeks.
In 2021, Huanuo Bio launched clinical human trials in 6 medical institutions such as West China Hospital of Sichuan University, and the recent interim data based on more than 270 clinical enrollment cases proved that Colation Colloidose showed safe and efficient traumatic and hemostatic effects in minimally invasive and refined surgery represented by minimally invasive gynecological surgery, orthopedic spine surgery, and general external minimally invasive surgery.
It can be seen that Colation Colloidose has pushed the product performance of high-end hemostasis consumables to a higher level, and is expected to significantly reduce costs and bring more cost-effective choices to doctors and patients.
According to Huanuo Biotech, "Coloidose is expected to be approved for Class III medical devices and enter the domestic clinic in early 2023." ”
Pioneered in "self-healing" material technology
Applied to clinical medical scenarios
The excellent performance of Kolloidose developed by Huanuo Biotech in a number of data is supported by its exclusive core "hard" technology - "self-healing materials". The so-called self-healing material is that the material can independently restore its structure and mechanical strength after being damaged by force, just like the liquid metal robot in the classic science fiction movie "Terminator II" can heal instantly after being injured. The medical materials developed by Warner also exhibit self-healing properties, and the material can heal the incision within seconds after the material is cut, restoring the initial structure and strength.
The liquid metal robot in the classic sci-fi movie Terminator II heals instantly after being injured
Huanuo's self-healing gel material "Black Technology" technology is independently developed
It is reported that the design of imported hemostatic fluid products is composed of millimeter-size gelatin particles, and the gelatin particles are mixed with liquids such as normal saline during use to obtain a paste-like injectable fluid, with low viscosity and no solid gel material with mechanical strength, so it is called "fluid".
In the process of hemostasis, the accumulation of gelatin particles in the bleeding trauma site achieves a physical barrier, but this design mechanism will inevitably lead to the low mechanical strength of the hemostatic material, and it is difficult to achieve rapid hemostasis on the wound surface with large bleeding volume and high mechanical strength requirements, resulting in narrow indications, which is not suitable for carotid artery bleeding, which is not suitable for carotid artery bleeding.
Huanuo Bio has chosen a different technical route from imported products, and Koning Colloidose adopts the design principle of self-healing gel materials.
Dr. Wang Huanan is a doctor of biomedical engineering from Sichuan University, a doctorate from the School of Medicine of the University of Neemgen in the Netherlands, a postdoctoral fellow at Harvard Medical School and school of engineering, with more than 20 years of research foundation in the field of biomaterials, and as early as 2010, he was conducting technology research and development and basic research on self-healing gel materials.
According to Dr. Wang Huanan, self-healing materials are the frontier hotspots in the field of smart materials, which were proposed by two American scientists, White and Professor Sottos, in 2001, and were selected as one of the top 20 new materials that will change the future by the top science and technology review journal "MIT Science and Technology Review", but the application of such innovative materials technology in the medical field is still blank.
Founded in 2017, Huanuo Biotech is the world's first industrial company to apply self-healing material technology to human clinical medical scenarios, filling the international and domestic gaps.
Compared with imported hemostatic fluid based on millimeter particle accumulation hemostasis, Warno Biotech Colagulation Colloidose Hemostatic Gel is based on the principle of self-repair, and the gel material exhibits shear thinning and self-healing properties, which is reflected in the fact that after injection, the gel can begin to recover its structure and mechanical strength at a second-level speed, and can be solidified into a gel within a few seconds after injection to the wound without introducing chemical crosslinking reaction, and forming sufficient mechanical strength to achieve sealing and compressing hemostasis of the bleeding wound.
Huanuo Bio platform "hard technology" - the technical principle of self-healing colloidal materials
In addition, coagulation Colloidose relies on the small size effect of submicron gelatin colloidal particles, has a higher specific surface area, and gelatin has excellent swelling properties, can quickly absorb blood components, so that the blood is rapidly dehydrated, so that a large amount of adhesion to blood cells and platelets can be realized, and blood coagulation can be accelerated. At the same time, it can adsorb fibrinogen in the blood, activate its own coagulation effect and further promote blood clotting.
Triple hemostatic effect of Warnor Bioscience Colloidose hemostatic gel
Therefore, based on the innovative technology of self-healing gel, Colation Colloidose has greatly improved the physical strength, achieved two or more orders of magnitude of strength improvement compared with imported products, and can stably stop carotid bleeding, and has bright performance in the average effective hemostasis time, wound healing, and material degradation.
Self-healing material technology is extremely malleable,
Suitable for multiple scenarios of regenerative medicine
In the future, the trauma of surgical surgery is getting smaller and smaller, and minimally invasive surgery must be the general direction of the priority choice for doctors and patients to perform surgery. In this direction, the market prospect of degradable biomedical materials, especially high-end hemostasis consumables, is worth looking forward to, and the scale will rapidly expand with the increase in the number of minimally invasive surgeries.
Moreover, in ordinary open surgery, there has also been a trend of minimally invasive precision hemostasis consumables to accelerate the replacement of traditional hemostasis consumables, according to statistics, the current application of injectable hemostatic consumables in general surgery open surgery has accounted for more than 21%.
"In response to the needs of trauma repair, in the future, biomedical materials will have more complex functions in addition to hemostatic functions, such as controlling inflammatory infections around trauma and delivering growth factors that induce bone growth." These are the directions in which Huanuo Bioscience Colation Colloidose Hemostatic Gel can be expanded, and now the team has confirmed that hemostatic gel consumables can achieve long-term sustained release of protein factors, can be used as a gel carrier for cell culture to achieve immune isolation and cell induction, can be used as a carrier for small molecule drugs such as antibiotics or anesthetics, and can also be used as medical beauty filler materials to provide better fibrous tissue regeneration. ”
"Huanuo Biocolcoagulable Colloidose Hemostatic Gel will be more than a simple hemostatic consumable, but an innovative 'golden oil' type medical carrier that can expand more functionality and better therapeutic effects." Dr. Wang Huanan said.
It is worth noting that Huanuo Bio's self-healing medical material glue belongs to the underlying general technology and has great ductility.
Huanuo Bio is aiming at the regenerative medicine market, trauma repair is the first step, and is currently developing products including hemostatic consumables and tissue bonding materials. Followed by orthopedics, medical aesthetics, oral clinical direction, the company's research and development of injectable bone repair gel has the same composition as bone tissue, can effectively promote the growth of new bone.
"The commonality of these clinical consumables product development is a new type of medical material for minimally invasive and precision surgical scenario applications. At the same time, the self-repairing material platform can be used as the basic carrier for application directions such as 3D printing, cell delivery, drug carrier, tissue engineering and organ manufacturing, and Huanuo Bio expects to establish cooperation with more upstream and downstream industries to jointly expand the application scenarios and markets of new medical carriers. The ultimate goal is to rely on self-healing gels as the underlying technology to provide a complete solution for regenerative medicine. ”