Technology/Product Details

Technologies

Medical Devices

1.  External Pneumatic Compression Equipment(EPSE) for Deep Vein Thrombosis (DVT) prophylaxis

Device Classification:
Class B


Area of Application:
Cardiovascular


TRL:
TRL4


1
Technology
To improve venous circulation in the limbs of patients suffering from Deep Vein Thrombosis

Clinical relevance
Deep vein thrombosis (DVT) is a serious disorder with an estimated annual incidence of 1 per 1,000 persons per year and a lifetime incidence of 2% to 5%.The major outcomes include mortality, thromboembolism and bleeding.

Product
EPSE consists of two parts: one a wearable unit that consists of a set of bladders (foot/ ankle or calf) and an external pumping unit connected to the former through a hose. After worn the bladders are inflated one after the other maintaining the pressure which can be set (20 to 100 mmHg) for some seconds. And then it is deflated one by one approximately 6 mmHg for 60 seconds. A soft starting air pump ensures better efficiency. Alarm mechanism is available. The device is programmable, portable and power backed. Indian Patent filed - An external pneumatic compression device for prevention of deep vein thrombosis, 046/CHE/2014.

Scope
The industry can associate for technology transfer; carry out the field trials and further commercialization.

2.  Electromagnetic Blood flow meter

Device Classification:
Class C


Area of Application:
Cardiovascular


TRL:
TRL3


1
Technology
For measurement of flow of blood and other priming fluids in an extracorporeal circuit during cardiac bypass surgeries.

Clinical relevance
The measurement and analysis of any conductive fluid, more particularly the measurement of flow of blood and other priming fluids in an extracorporeal circuit during cardiac bypass surgeries is essential. A compact device that would have high immunity to external noises and drift and eliminate the DC offset due to polarization would prove advantageous.

Product
An electromagnetic flow meter to measure the velocity and flow rate of blood and other conductive fluids used in bypass surgeries and dialysis in a cost effective way is developed. The flow meter consist of a handy probe and a signal processing system having a novel signal processing technique which enables the measurement to have better sensitivity, accuracy and stability to environmental changes.Portable battery operated variant is also developed.
Experimental analysis on prototype developed shows a higher sensitivity in flow variation and accuracy higher than 95%.
Indian patent filed: High sensitive current controlled electromagnetic blood flowmeter, 2894/CHE/2013.

Scope
In development stage. Industry capable of carrying out the evaluations and further commercialization may associate.

3.  Infant Warming wrapper/bassinet

Device Classification:
Class B


Area of Application:
Paediatric


TRL:
TRL3


1
Technology
Non contact warming of premature born babies having low birth weight using infrared energy while at hospital/home or during transportation.

Clinical relevance
Premature babies born with low birth weight are subjected to high temperature loss and may even die if the ambient temperature is not maintained at the core body temperature requirement of 370C. Hence such new born babies are kept in a warm environment to compensate for temperature loss and improve weight gain. Present technologies available are highly technical, less accessible, non portable and highly costly.

Product
A transportable, light weight, battery operated, infant warmer is developed which consists of a bassinet to keep the baby and a retractable warming pad on the top. The warming pad consists of a cluster of infrared light emitting diodes which emits infrared rays in the wavelength suitable for warming a baby. The thermal energy released by the cluster of IR diodes raise the temperature of the environment surrounding the baby to physiological condition. Since the warming pad is kept near to the baby’s body, only very little thermal energy of order of few tens of watts is required to keep the baby warm. A power controller with battery pack attached to the bassinet receives feedback signal from a set of temperature sensors distributed throughout the warming pad and controls the same. The power controller is equipped with temperature display over temperature alarm and other safety features.

Scope
Prototype developed. Industry shall collaborate and take forward the evaluations and commercialization

4.  Blood and IV fluid warming system

Device Classification:
Class B


Area of Application:
Hematology


TRL:
TRL3


1
Technology
Blood and IV fluid transfusion.

Clinical relevance
Even though Hypothermia is most common in patients who are exposed to a cold environment, it can develop secondary toxin exposure, metabolic derangements, infections, and dysfunction of the central nervous and endocrine systems Fluid warming is a method of raising the temperature of fluids administered to a patient to maintain normal body temperature and prevent hypothermia.

Product
A blood and IV fluids warming system suitable for slow as well as massive transfusion using infrared radiations emitted from distributed low power IR LEDs is developed. The system consists of a blood bag warming chamber and an inline IV tube warming cartridge having infrared light emitting diodes distributed throughout the inner surface and connected to a power controller. For massive transfusion, blood bag can be placed inside the bag warming chamber and the IV tube is passed through the small cartridge before connecting to the patient. The infrared radiations emitted by the LEDs warm the blood or IV fluid inside the bag to raise the temperature from refrigerated condition (4°C) to 37 °C in a few minutes.

Scope
Prototype developed. Industry shall collaborate and take forward the evaluations and commercialization

5.  Hydroxyapaptite bone graft substitutes

Device Classification:
Class D


Area of Application:
Orthopaedic


TRL:
TRL7


1
Technology
This technology consists of synthetic bone graft substitute based on hydroxyapatite, the bone mineral. The material is prepared through chemical reaction in implantable grade purity and converted to porous form through ceramic processing. This could be shaped into different sizes and geometries. The know-how has been developed indigenously and tested as per International standards. The intellectual property rights of the production process are protected.

Clinical relevance
The need for bone graft arises quite often in orthopaedics and spine surgeries, which is conventionally managed by autologous bone (patient’s own bone harvested from other sites). Synthetic bone grafts becomes helpful in augmenting the inadequacies in grafting or to replace the autologous bone and to avoid additional surgeries. Hydroxyapatite, being similar to bone mineral, is well accepted by the body without any adverse reaction. Synthetic bone grafts with hydroxyapatite porous ceramics integrate with host bone and helps in the natural healing process to regain the normal anatomy. The material is available off-the-shelf in any quantity.

Product
The product is basically hydroxyaptite ceramic bodies of 60-70% porosity with interconnected pores in the size 150-300µm. These correspond to the mineral part of cancellous bone. This can be supplied as granules (3-5 mm size) and blocks (up to 10mm cube).
This has undergone testing cycle based on ISO 10993 and completed clinical trials.

Scope
Prototype developed. Industry shall collaborate and take forward the evaluations and commercialization

6.  Calcium phospho silicate bone graft substitute

Device Classification:
Class D


Area of Application:
Orthopaedic


TRL:
TRL7


1
Technology
This technology consists of synthetic bone graft substitute based on calcium-phospho-silicate composite, which has high bioactivity. The material is prepared through chemical reaction in implantable grade purity and converted to porous form through thermal processing. This could be shaped into different sizes and geometries.
The know-how has been developed indigenously and tested as per International standards. The intellectual property rights of the production process are protected

Clinical relevance
The need for bone graft arises quite often in orthopaedics and spine surgeries, which is conventionally managed by autologous bone (patient’s own bone harvested from other sites). Synthetic bone grafts becomes helpful in augmenting the inadequacies in grafting or to replace the autologous bone and to avoid additional surgeries. Hydroxyapatite, the ceramic of bone mineral, is conventionally used. Silicate containing calcium and phosphorous ions (better known as ‘bioglass’), is considered as next generation bone graft compared to hydroxyapatite. It performs better, considering resorption and healing and helps to regain the normal anatomy faster . The material is available off-the-shelf in any quantity.

Product
The product is a glassy composite containing calcium-phospho-silicate phases. The porosity level is 60-70% with interconnected pores in the size 150-300µm. This can be supplied as granules (3-5 mm size) and blocks (up to 10mm cube).
This has undergone testing cycle based on ISO 10993 and completed clinical trials.

Scope
The know-how for the calcium-phospho-silicate graft substitute has been licensed. Multiple technology transfer is envisaged.

7.  Hydroxyapatite nanogel for root canal filling

Device Classification:
Class C


Area of Application:
Dental


TRL:
TRL6


1
Technology
This is a nano-gel formulation of hydroxyapatite intended for the filling of root canals after pulpotomy. This satisfies most of the ideal features of a root canal filler, i.e. easily administratable, conformally filling, non-shrinking, biocompatible and completely sealing. The know-how has been developed indigenously and tested as per International standards. The intellectual property rights of the production process are protected.

Clinical relevance
Root canal filling pastes are frequently used endodontic surgery to seal the root canal of pulp-infected tooth and to save it from extraction. An ideal root filling material should be able to administrate easily into the canal, should provide perfect sealing of the canal laterally as well as apically and should not shrink after application. Biocompatibility is an additional requirement. None of the present materials qualify these criteria. The nano-gel formulation of hydroxyapatite has proven to possess most of the characteristics. This has been particularly designed for deciduous teeth in pediatric cases where a biocompatible material is inevitable.

Product
The product consists of a special nano-gel of hydroxyapatite developed through a systematic development process. It comes as a pre-loaded injectable package convenient to transfer to root canals. It has passed the in vitro criteria prescribed by ISO/ANSI standards.

Scope
In vitro studies are completed.
Industry can associate to take forward with clinical evaluations.

8.  Calcium sulfate cement

Device Classification:
Class D


Area of Application:
Orthopaedic


TRL:
TRL6


1
Technology
Calcium sulfate cement comes as an alternative to its phosphate counterpart, retaining the properties like mouldability, resorbability and bioactivity. Major advantage is the simplicity and affordability of the material. It is a bioactive formulation of low-dimensional calcium sulfate intended for bone defect repair in orthopedic, spine and maxillofacial surgeries. It designed as powder, which upon mixing with water gives a self-setting putty. Pure calcium sulfate is made in-house and is modified with hydrogen orthophosphate ions so as to impart better biocompatibility and slower resorption.
This technology has been indigenously developed and translated to clinical application. The intellectual property rights of the production process are protected.

Clinical relevance
Bone defect repair in orthopedic, spine and maxillofacial surgeries calls for a mouldable bioactive cement material which will be helpful in grafting inaccessible sites and to build contours. This new bioactive calcium sulfate cement is a highly affordable option for bone filling. It sets by mixing with water and integrate with bone in vivo during 6-9 months.

Product
This is simple and affordable bone filler cement based on calcium sulfate, setting in water medium. The setting time will be 12-16 minutes and after setting the mass will develop strength of 10-12 MPa, comparable to spongy bone.

Scope
Pre-clinical studies completed. Clinical trials in progress.
Technology is transferred to an industry. Multiple transfers are envisaged.

9.  Visible light cure dental restorative composite based on organically modified ceramic resin
Device Classification:
Class C


Area of Application:
Dental


TRL:
TRL4


1
Technology
Material for dental restoration with good handling properties.

Clinical relevance
Conventional restorative materials are based mainly on organic resins such as BisGMA or UDMA and inorganic fillers like quartz or glass. Although these conventional restorative materials have proven to be highly effective at preserving teeth, they have a limited life-span and ultimately require replacement. Ineffective bonding with the inorganic filler and organic matrix is one of the main causes for polymerization shrinkage. Most common reasons for secondary caries are polymerisation shrinkage of dental composites and biofilm (plaque) formation on the margin of the tooth and restoration. Moreover, a significant percentage of these restored teeth ultimately undergo pulpal necrosis, requiring either tooth extraction or endodontic treatment and prosthetic build up. Therefore, development of novel techniques to regenerate, as opposed to repairing, lost tooth structure would have significant benefits.

Product
The product is a visible light cure non-radiopaque dental restorative composite.It is used for the development of a non-radiopaque bioactive composite with low polymerization shrinkage and better physico-mechanical properties. It can be applied all types dental restorations due to its good handling properties .This products contain no Bisphenol A, no Bis-GMA, no BPA derivatives, All the materials can be polymerized using visible light The shelf life period of the composite has evaluated and found to be more than three years.

Scope
Completed all the physico mechanical, invitro and invivo biocompatibility evaluation including Pulp and Dentin test in Dog model and histopathology evaluations as per the international standard. Ready for technology transfer – industry can associate to take forward the clinical trial and further commercialization.

10.  Visible light cure Radiopaque composite based on Ormoresin

Device Classification:
Class C


Area of Application:
Dental


TRL:
TRL4


1
Technology
Non-radiopaque bioactive composite with low polymerization shrinkage and better physico-mechanical properties for dental restorations.

Clinical relevance
Conventional restorative materials are based mainly on organic resins such as BisGMA or UDMA and inorganic fillers like quartz or glass. Although these conventional restorative materials have proven to be highly effective at preserving teeth, they have a limited life-span and ultimately require replacement. It can be applied all types dental restorations due to its good handling properties .This products contain no Bisphenol A, no Bis-GMA, no BPA derivatives, All the materials can be polymerized using visible light.

Product
This product is a visible light cure radiopaque composite with low polymerization shrinkage and better physico-mechanical properties. The composite can be applied to larger cavities and root canal applications. Ideal for all restoration classes. The radiopacity is equivalent to 1.5mm of aluminum.
Indian Patent (Patent Number 219733).

Scope
Completed all the physico mechanical,invitro and invivo biocompatibility evaluation including Pulp and Dentin test in Dog model and histopathology evaluations of the non -radiopaque composite based on this resin as per the international standard. Ready for technology transfer – industry can associate to take forward the clinical trial and further commercialization.

11.  VLC Bioactive Composite

Device Classification:
Class C


Area of Application:
Dental


TRL:
TRL4


1
Technology
Restorative material ideal for larger cavities and root canal applications.

Clinical relevance
Bioactive dental materials stimulate apatite formation that fills gaps, seals margins against microleakage, and helps rebuild teeth. Bioactive materials that are strong, esthetic, and long-lasting offer an alternative to traditional composites, which are strong and esthetic but are passive and without bioactive potential . Dentactive seals margins against micro¬leakage, secondary caries, and failure.responds to pH cycles and plays an active role in maintaining oral health with release and recharge of significant amounts of calcium, and phosphate. These mineral components stim¬ulate formation of a protective/connective apatite layer and a natural bonded-seal at the material-tooth interface.Remarkable advantages are:

  • Non-sticky, good marginal adaptation
  • Less shrinkage than conventional composites
  • Very good dentine and enamel bonding with Sted Bond

  • High shade matching and colour stability

    Product
    The product is bioactive, radiopaque composite with low polymerization shrinkage and better physic-mechanical properties for restorative applications. The novel bioactive visible light cured dental composites were based on novel bioactive inorganic-organic hybrid resins with polymerizable methacrylate groups synthesized through modified sol-gel method.
    Indian Patent filed: Application Number 4996/CHE/2014.

    Scope
    Industry can associate to take forward the clinical trial and further commercialization.

    12.  Bioactive Composite with Antimicrobial properties

    Device Classification:
    Class C


    Area of Application:
    Dental


    TRL:
    TRL4


    1
    Technology
    A bioactive visible light cure dental composite with better antimicrobial properties.

    Clinical relevance
    Saliva is a natural caries protection agent and contains the minerals that maintain the integrity of the enamel surface.It helps maintain the health of the hard and soft tissues, removes waste, and protect against microbial invasion. Bioactive dental materials help regulate the chemistry of teeth and saliva and contribute to the remineralization.

    Product
    The product exhibited antimicrobial property compared with control Bis GMA based composite when exposed to E.coli ATCC 25922 bacteria for an exposure of 1 hour.

    Advantages are :
  • Esthetic
  • Chemically bonds
  • Seals teeth against bacterial leakage
  • Releases/recharges calcium and phosphate
  • Provides long-term patient benefits

  • Scope
    Industry can associate to take forward the clinical trial and further commercialization.

    13.  Hydroxyapatite dense spacers

    Device Classification:
    Class D


    Area of Application:
    Orthopaedic


    TRL:
    TRL7


    1
    Technology
    This is a specific synthetic bone graft substitute design based on hydroxyapatite, the bone mineral. Highly dense and strong hydroxyapatite ceramic is prepared in wedge shape to provide support to the expanded vertebra in laminoplasty surgery. The material is prepared through chemical reaction in implantable grade purity.
    The know-how has been developed indigenously and tested as per International standards. The intellectual property rights of the production process are protected.

    Clinical relevance
    Laminoplasty is performed to treat spinal stenosis in the neck or low back. The lamina of the vertebra is carefully cut and expanded to create more space in the spinal canal, which relieves pressure from the spinal cord and nerve roots. Small wedges or pieces of bone are placed so that the enlarged spinal canal will remain in place.
    This product acts as strong biocompatible wedge which will integrate with bone.

    Product
    This is a dense hydroxyapatite ceramic body shaped as a wedge, compatible with the sizes of the vertebrae.
    The product has undergone testing cycle based on ISO 10993 and completed clinical trials.
    1

    14.  Hydroxyapatite based cranial burr hole closure device

    Device Classification:
    Class D


    Area of Application:
    Orthopaedic


    TRL:
    TRL7


    1
    Technology
    The product is a mushroom-like plug of hydroxyapatite material, applicable for the closure of cranial burr-holes remaining after brain surgery. The button has a special bi-layer structure with a dense upper layer and a porous lower layer, designed as monolithic piece using a special slip-cast technique. This mimics the cranial bone and proven to integrate with human bone.
    The know-how has been developed indigenously and tested for clinical efficacy. The intellectual property rights of the production process are protected.

    Clinical relevance
    Burr hole trephination is a safe and effective surgical option to treat patients with chronic subdural hematoma (CSDH). However, it often results in a small but undesirable scalp depression from burr-hole defect. This is a bothersome cosmetic problem and also functional handicaps to the patients especially during hairdressing or combing. Covering the burr-hole with a synthetic bone graft material is the ideal option to solve this problem.

    Product
    The product is made out of hydroxyapatite with a unique bi-layer structure with differing porosities, corresponding to the cortico-cancellous structure of the cranial bone. The sizes are compatible with the surgical defects. 1

    15.  Calcium-phospho-silicate composite periodontal graft material

    Device Classification:
    Class C


    Area of Application:
    Dental


    TRL:
    TRL7


    1
    Technology
    This technology consists of fine granules of bioactive material based on calcium-phospho-silicate composite. It is prepared through chemical reaction in implantable grade purity and converted to porous form through thermal processing and graded in fine particulate size. It is useful for filling periodontal bone defects in dentistry.
    The know-how has been developed indigenously and tested as per International standards.
    The intellectual property rights of the production process are protected.

    Clinical relevance
    Periodontal defects and periapical cysts are common problems observed in dentistry. Fine granules or chips of bone graft materials are needed for the defect healing. Hydroxyapatite ceramics is less preferred because of slow resorption. Calcium-phospho-silicate bioactive composites enable faster healing of the defects in periodontal bone.

    Product
    The material contains nano level composite of hydroxyapatite, tricalcium phosphate and calcium silicate, manufactured through solid phase reaction between hydroxyapatite powder and bioactive glass powder (having calcium, phosphate and silica). It is converted to composite ceramic form and crushed and graded to obtain granules of 300-700 microns size. The material is found to be bioactive and fast resorbing compared to bare hydroxyapatite ceramics.
    The product is useful for filling periodontal defects, extraction sites and ridge augmentation. Also useful in filling peri-apical cysts.

    Scope
    The know-how for the calcium-phospho-silicate composite periodontal graft material has been licensed and the product is available in the market. Multiple technology transfers are envisaged.

    16.  Calcium phosphate bone cement

    Device Classification:
    Class D


    Area of Application:
    Orthopaedic


    TRL:
    TRL7


    1
    Technology
    Calcium phosphate cements are new-generation bone filler materials, combining mouldability, resorbability and bioactivity. They are designed as powder-liquid combination, which upon mixing, gives a self setting putty. Upon setting, it will get converted to hydroxyapatite. This technology has been indigenously developed and translated to clinical application. The intellectual property rights of the production process are protected.

    Clinical relevance
    Bone fillers are in regular use in day-to-day orthopedics and dentistry to cover the additional gaps of implant or graft placement. Calcium salts are preferred rather than ceramic material for bone filling purpose. The advent of calcium phosphate cement was a significant development because it gave a mouldable, resorbable and bioactive material for filling applications. This cement helps in the management of bone defects in bone, spine and maxillofacial structures.

    Product
    The calcium phosphate cement product comes as powder-liquid combination. Mixing the powder with the liquid in the prescribed ration will give a self-setting putty. The setting time will be 12-16 minutes and after setting the mass will develop a strength of 10-12 MPa, comparable to spongy bone. This will get resorbed in vivo and get replaced with bone in a period of 6-9 months.

    Scope
    The know-how for the calcium phosphate cement has been licensed and the product is available in the market. after DCGI approval. Multiple technology transfers are envisaged. All the documents are available to obtain the production license and marketing approval.

    17.  Bioactive calcium sulfate cement

    Device Classification:
    Class D


    Area of Application:
    Orthopaedic


    TRL:
    TRL6


    1
    Technology
    Calcium sulfate cement comes as an alternative to its phosphate counterpart, retaining the properties like mouldability, resorbability and bioactivity. Major advantage is the simplicity and affordability of the material. It is a bioactive formulation of low-dimensional calcium sulfate intended for bone defect repair in orthopedic, spine and maxillofacial surgeries. It designed as powder, which upon mixing with water gives a self-setting putty. Pure calcium sulfate is made in-house and is modified with hydrogen orthophosphate ions so as to impart better biocompatibility and slower resorption.
    This technology has been indigenously developed and translated to clinical application. The intellectual property rights of the production process are protected.

    Clinical relevance
    Bone defect repair in orthopedic, spine and maxillofacial surgeries calls for a mouldable bioactive cement material which will be helpful in grafting inaccessible sites and to build contours. This new bioactive calcium sulfate cement is a highly affordable option for bone filling. It sets by mixing with water and integrate with bone in vivo during 6-9 months.

    Product
    This is simple and affordable bone filler cement based on calcium sulfate, setting in water medium. The setting time will be 12-16 minutes and after setting the mass will develop strength of 10-12 MPa, comparable to spongy bone.

    Scope
    Pre-clinical studies completed. Clinical trials in progress.
    Technology is transferred to an industry. Multiple transfers are envisaged.

    18.  Recombinant proteins - Transformation growth factor-alpha (TGF-alpha) and Vascular endothelial growth factor (VEGF)

    Device Classification:
    Class D


    Technology
    Development of Recombinant human TGF-alpha and VEGF using genetic expression in prokaryotic system.

    Clinical relevance
    Growth factors contribute significantly to the repair and regeneration of tissues

    Product
    The products are developed using genetic expression in prokaryotic system and purified using chromatographic techniques. Both these recumbent proteins are developed by a cloning strategy by which the functionally active recombinant peptides are developed (similar to the native post-translated modified peptides). International/Indian Patent filed.

    Scope
    The technology is at a Proof of Concept stage.

    19.  Immunoisolation bags / prototype biohybrid pancreas

    Device Classification:
    Class D


    1
    Technology
    Technology for selective permeability of secretory lower molecular weight ( less than 20Da substances)

    Clinical relevance
    The technology can be fashioned as a biohybrid pancreas or a depot for the controlled release of dopamine or chromaffin etc.

    Product
    An implantable device that is non toxic and non degradable, which is semipermeable to low molecular weight drugs, proteins and enzymes and is also impermeable to higher molecular weight immunoglobulins. The device is in the form of a bag and can also be fabricated in different other shapes. International/Indian Patent filed.

    Scope
    The product is in the development stage.

    20.  Albumin as curcumin delivery vehicle for anti-cancer activity

    Device Classification:
    Class D


    1
    Technology
    For producing water soluble curcumin without losing its drug action with potential anticancer properties.

    Clinical relevance
    Most of the anti-cancer drugs damage many cell types; therefore, intense research discovered new molecules but with various limitations. Curcumin is a natural molecule that proves potential anti-cancer properties for human use. But its poor aqueous solubility and bioavailability limits its effective use. The technology tries to address this limitation.

    Product
    Chemical-free conjugation to native albumin with high binding efficiency achieves high concentration of biologically active curcumin in aqueous medium. Curcumin solubility in conjugated form is 100 fold higher than free curcumin. Internalization of Curc-Alb into the cancer cell has been demonstrated. Action of Curc-Alb on cancer cells has been established in vitro and in vivo. No study has reported earlier that conjugated albumin has anticancer and anti-angiogenic activity at a concentration which is non-toxic to primary fibroblast.
    Human albumin in its native form and pH is used for conjugation of Curcumin. Albumin is normally concentrated at the tumor site. Albumin infusion to cancer patients is a standard therapeutic method. So transfusion of Curc-Alb conjugate may not cause hazard to the patient as compared to many caustic drugs given for treatment.
    Patents: (i) Alb-Curc (PCT/IN2014/000338)

    Scope
    Pharamacokinetics/ Pharmacodynamics (PK/PD) study in progress
    Industry can collaborate for further development and commercialization

    21.  Polymeric microneedles

    Device Classification:
    Class B


    1
    Technology
    Painless delivery of drugs/molecules in controlled fashion

    Clinical relevance
    The micro-needle (MN) patch is aimed at delivering drugs/biomolecules in a controlled fashion. This technique can also be used for delivering vaccines painlessly. The microneedle patch could also be used for mechanical anchoring of skin grafts/substitutes in plastic surgery.

    Product
    A micro-needle (MN) patch of polymeric materials, which consists of a micro-needle array and a plate where the micro-needles are standing and aligned on, wherein the micro-needles are 100-300 μm in length, can convert from hard solid state to hydrogel state by absorbing water for controlled drug/bioactive agent delivery.The MN patch is capable of controlled delivery of drugs/biomolecules and vaccines painlessly. Some drugs are already tested for controlled release.

    Scope
    Requires further work on controlled drug delivery of various drugs. Collaborative development along with an industrial partner is the mode envisaged.

    22.  X ray opaque polyurethanes

    Device Classification:
    Class A


    1
    Technology
    For Fabrication of radiopaque medical devices (e.g., catheters, tubings, etc), Radiopaque coatings for medical or non-medical devices, X-ray shielding devices.

    Clinical relevance
    Finds application in both medical and non-medical applications wherever X-ray shielding is important.

    Product
    Polyurethane materials with iodine in the polymer chain. They are produced by iodinating diols and incorporating them in the polymer chain during the polymerization process.These are light weight polymeric materials with in-built X-ray opacity. No radiopaque additives are added in the polymer.Patent application filed.

    Scope
    In development stage –collaborative work with industry solicited for different applications.

    23.  Fibrin Wafer

    Device Classification:
    Class B


    Technology
    High efficient hemostats to arrest bleeding.

    Clinical relevance
    Surgical bleeding often causes excessive blood loss needing several units of blood transfusion. Most of the hemostats available currently are not capable of inducing hemostasis at major internal surgical sites with high bleeding tendency. Also most of them are not absorbable. So there is a need to develop high efficiency hemostats to arrest bleeding.

    Product
    Lyophilized fibrin wafer with good porosity for penetration of blood is produced from human plasma derived fibrin sealant. Upon entry into the fibrin wafer, blood clotting is promoted by high concentration of active thrombin available. With time, the fibrin gets degraded by the natural fibrinolysis mechanism and the degradation products are resorbed.
    Only Pharmacopoeia grade fibrin sealant is used in the product. The lyophilized FW is designed as an off- the-shelf product with >2 year shelf life. The degradation and clearance of FW within 30 days of use as hemostat applied on rabbit liver tissue has been demonstrated. There is no fibrotic reaction in the liver tissue which assures safety of the product.

    Scope
    Industry shall associate with the development in developing the packaging and conduct of clinical trials.

    24.  Fibrin Wafer for Curcumin Delivery

    Device Classification:
    Class C


    1
    Technology
    Fibrin wafer for curcumin delivery with potential anticancer properties

    Clinical relevance
    Cancer metastasis after surgical resection of cancer tissue is a major health problem leading to mortality. Most of the anti-cancer drugs are toxic to different cell types. Therefore, local delivery of cancer drug at the surgical site has effective implications in cancer treatment to prevent remission. Curcumin conjugated to human albumin (Curc-Alb) has potent apoptotic effect on cancer cell which can be used to prevent and treat cancer. Technology for effective sustained drug delivery of Curc-Alb at the site of resected tumor promises major medical significance.

    Product
    Fibrin wafer incorporated with Curc-Alb has been designed to be implanted at the surgical site. Because Curc-Alb is highly soluble in water, it is mixed with components of Fibrin Sealant before clotting it in specific dose and dimension. The lyophilization of clot produces a wafer which releases curcumin for long periods depending on the initial dose incorporated into the wafer.
    Salient features are fibrin is adhesive to surgical, bleeding tissue; so, application is easy. Added advantage is it can be hemostatic and helps in arresting excessive bleeding. A single product for inducing haemostasis and for sustained release of a proven drug in soluble form, constructed using only human proteins in a stable, ready-to-use form.
    : (i) Alb-Curc (PCT/IN2014/000338) ; Fibrin wafer / disc (PCT/IN2014/000338)

    Scope
    Industry shall associate with the development in conduct of clinical trials and further commercialization.

    25.  Skin Substitute : PLGC-F-HA

    Device Classification:
    Class C


    1
    Technology
    Hemostat for diabetic and burn subjects

    Clinical relevance
    Deep wounds in diabetic and burn subjects often become a health problem leading to morbidity and mortality. Currently, autologous skin grafting is the Golden Standard to treat such wounds; many of the wound care products available in the market are not suitable for skin substitution. The available products are costly.

    Product
    PLGC-F-HA is a novel hemostatic substitute indicated for full thickness skin wounds. The product is a combination matrix formed from human plasma derived, pharmacopoeia grade Fibrin Sealant (F), hyaluronic acid (HA) and synthetic degradable monomers which are approved by USFDA for clinical use. The PLGC synthesized and characterized is provided as a nanofibrous electrospun mat with fibers ranging from 5 to 80 nm in diameter embedded in polymerized human F and HA.
    PLGC-F-HA was developed to match the physicochemical properties of native skin in terms of tensile strength, water permeability and elasticity. The polymerized fibrin imparts hemostatic adhesion for suture-less application on the relatively fresh, debrided wound and remains till the wound is healed. Safety of PLGC was proven using selected toxicological tests from ISO10993. The human fibrin is pharmacopoeia grade and does not leave any additional risk. Hyaluronic acid is isolated (>99% purity) from human umbilical tissue without using an in-house standardized method.

    Scope
    Industry shall collaborate and take forward the evaluations and commercialization.

    26.  PVA sponge

    Device Classification:
    Class A


    1
    Technology
    Single use, sterile, lint free sponge

    Clinical relevance
    The sponge being hydrophilic can act as water absorbent.

    Product
    A lint free sponge which can be used as such and/or manipulated with the help of tweezers or can be attached to a malleable handle. These are single use only, sterile devices designed for tissue manipulation and fluid management.

    Scope
    Prototype developed. Industry shall collaborate and take forward the evaluations and commercialization.

    27.  Fibrin sealant

    Device Classification:
    Class C


    1
    Technology
    Fibrin sealant from small batch pools of plasma

    Clinical relevance
    Fibrin Sealants are two component systems that are approved for use as hemostatics, tissue sealants, and tissue adhesives.

    Product
    This fractionated plasma product meets listed specifications in the European/Indian Pharmacopoeia (IP) & WHO regulations for efficacy and safety, respectively. The product kit comprises mainly lyophilized fibrinogen and thrombin with >1y storage stability till reconstitution, just prior to use, in respective solvents included in the kit. Dual syringe applicator assembly in the kit ensures optimum mixing and the clot forms within 2-5s. Intended applications of Fibrin Sealant could be as biological soft tissue adhesive, as adjunct to surgical sutures and/or to promote haemostasis.

    Scope
    Prototype developed. Industry shall collaborate and take forward the evaluations and commercialization.

    28.  De-cellularised Bovine Pericardium for Cardiovascular Patch Applications

    Device Classification:
    Class D


    Technology
    For Cardiovascular patch applications for cardiovascular surgery

    Clinical relevance
    In India it is estimated that 180,000 children are born with Coronary Heart Disease (CHD) every year. Of these nearly 60,000 to 90,000 suffer from critical CHD requiring early intervention. Surgical corrections of these conditions such as tetrology of fallout, pulmonary atresia,transposition of great arteries with Ventricular Septal Defect (VSD) and pulmonary stenosis requires cardiac patches or valved conduits all of which are currently imported. Decellularised animal tissue provide excellent choice for fabrication of cardiac patches and valved conduits because of their performance characteristics compared to materials such as metals, plastics or fabrics.

    Product/Process
    BSE free bovine pericardium was sourced for development of the product from Kerala Livestock Development Board (KLDB), a Government of Kerala Organization which has moderate cattle farms with ISO 9001 certification.
    The animal tissue was collected from well monitored, healthy, disease free herds of KLDB as per International standards, ISO 22442-2 and is tested for BSE and other relevant bovine diseases.This traceable tissue of biomedical quality was subjected to a de-cellularisation process developed at the Institute.
    The process renders it less immunogenic and less calcifying at the same allows better host tissue incorporation. De-cellularised bovine pericardium thus developed was subjected to preclinical testing as per relevant international standards to qualify its use as cardiovascular patch.

    Scope
    Industry can associate to take forward the clinical trial and further commercialization.

    29.  Glutaraldehyde cross-linking of pericardium with anti-mineralization treatment

    Device Classification:
    Class D


    1
    Technology
    Cardiovascular patch/Dural substitute/valved conduit

    Clinical relevance
    In India it is estimated that 180,000 children are born with Coronary Heart Disease (CHD) every year. Of these nearly 60,000 to 90,000 suffer from critical CHD requiring early intervention. Surgical corrections of these conditions such as tetrology of fallout, pulmonary atresia,transposition of great arteries with Ventricular Septal Defect (VSD) and pulmonary stenosis requires cardiac patches or valved conduits all of which are currently imported.
    Decellularised animal tissue provide excellent choice for fabrication of cardiac patches and valved conduits because of their performance characteristics compared to materials such as metals, plastics or fabrics.

    Product/Process
    An import substitute for imported gluteraldehyde treated pericardium. Proof of concept study was done in animal models of calcification. This material was found as non calcifying and non – cytotoxic. Validation of this process in buffalo pericardium is completed with respect to mechanical properties.

    Scope
    Industry can associate to take forward the clinical trial and further commercialization.

    Processes

    1.  System for vapour polishing of plastic components

    Technology
    Improving the surface finish of plastic components through vapour polishing.

    Clinical relevance
    The technology finds application in medical and non medical fields. In devices where surface smoothness is important the technology can be applied.

    Product/Process
    In this system the component to be polished is placed inside a temperature controlled chamber for vapor polishing and a measured quantity of solvent is delivered into the chamber; the exposure time is adjusted to achieve the required surface finish. The design of the chamber ensures complete vaporization of the fluid without droplet formation. By using a controlled quantity of solvent and varying the exposure time (without increasing the exposure volume) effective polishing is achieved on the plastic component with minimum quantity solvent and minimum environmental hazard. Polymers like polycarbonate can be polished without crazing. Indian patent filed.

    Scope
    Any industry who would like to adopt the process may associate.

    2.  Diamond like carbon based protective coating(RAXACOAT®)

    1
    Technology
    Diamond Like Carbon (DLC) is known to be the material ranking top in blood compatibility and tissuecompatibility. High wear resistance and corrosion resistance along with low friction make DLC the most ideal material to protect the metallic implant surface. High quality DLC coating fit for coating biomedical devices has been developed through a special process using a dedicated semi-industrial scale coating machine. The technique is basically a radio-frequency (RF) powered plasma enhanced chemical vapourdeposition (PECVD). This proprietary DLC coating know-how is protected with trademark RAXACOAT) and patents.

    Clinical relevance
    Metals and alloys are widely used in medical devices for their superior mechanical properties and ease of fabrication. However, metal surfaces undergo corrosive attacks (chemical as well as cell-mediated) in vivo. The corrosion products are likely to create local tissue problems. Thus, it is imperative to protect metallic implants using a mechanically strong, adherent and biocompatible coating. Diamond Like Carbon (DLC) is considered to be the most ideal in this respect.
    DLC is particularly useful in protecting the indwelling metallic devices like stents, blood contacting devices like heart valves and articulating devices like hip prostheses. Also it finds use in tools and instruments allied in micro surgery procedures, due to the anti-reflective properties.

    Product/Process
    The process developed in the dedicated PECVD equipment provides a unique Diamond Like Carbon (DLC) coating which is biocompatible and highly adherent to the metallic surface. The coating is pinhole-free and has high mechanical strength and modulus. It is proven to be wear resistant with very low surface friction coefficient.

    Scope
    Diamond Like Carbon (DLC) coating technology is ready for implant coating applications. Industry can utilise the coating technology for their metallic implant products.

    3.  Validation of Ethylene Oxide / Steam Sterilization equipment/process

    Technology
    To qualify the Ethylene oxide and steam sterilization process in healthcare facilities.

    Clinical relevance
    Sterilization need to be carried out in healthcare facilities, industrial environments and laboratories regularly. Use of super heated steam and ethylene oxide for healthcare facilities and industrial sterilization are established procedures. In order to build confidence in the process of sterilization certain validation procedures need to be carried out.

    Product/Process
    The process includes
  • Selection and installation of a suitable sterilization equipment/system which will perform the sterilization with repeatability in process parameters and performance
  • Selection of a sterilization method which is suitable to the requirements ie, which is suitable to the type of load that will ensure the required levels of microbial survivor index(MSI)
  • Development and qualification of the sterilization system, including the process.
  • The validation of the process used for the sterilization is an important step in assuring repeatable and reliable sterilization. During the validation, sterilization process must demonstrate to deliver required sterility assurance level, so that the load meets the end user requirements.

  • Scope
    Industry interested to adopt the process to their system may approach.