Expertise

Overview

We have specialized in the pre-clinical evaluation and development of novel therapeutics and medical devices in wide range of  therapeutic areas.

Our expertise ranges from early stage proof of concept to large-scale studies, safety and efficacy assessments for regulatory submissions.

We serve as a One stop shop by providing comprehensive integrated services from study design to execution including ethical submission, model selection, protocol writing, drug and medical device performance evaluation, study analysis and final reports.

Our Value Proposition 

  • Deep Knowledge and Demonstrated Experience with Large Animal Studies.
  • Large Scale Pre-Clinical Studies Enabled By:
    • In-house large animal (pigs) breeding facility with constant availability of pigs with high variation in size and stress-free animals (no transportation).
    • Constant follow-Up And Supervision of Animals.
  • Expedited Ethical Committee Approval.
  • All Under One Roof: From Large Animals Breeding to large scale Studies.
  • State of The Art follow-up -environment Facilities:
    • Surgical suites, imaging equipment, acclimation and follow up units.
  • Strong Team, Experienced Veterinarians & Network of Surgeons.
  • Innovative Large Animal Disease Models.
  • Innovative and Tailored Solutions Through the Entire Pre-Clinical Phase

Therapeutic Areas

We have extensive experience in cardiovascular and broad range of other therapeutic areas: Dermatology, Gastrointestinal, Metabolic Disorders, Renal & Urinary, Respiratory, Dental Medicine, Orthopedic, Pain Management and Drug Delivery.

Models

Internazal

Pig Model For CARPA- Complement Activation-Related Pseudo Allergy to evaluate the safety of drug delivery formulations, carriers, liposomal formulations and lipid excipients.

The pig is useful as a model for human physiology and pathophysiology, because many organ systems resemble those of the human. In addition, according to previous publication the use of the porcine CARPA model as a screening test for the in vivo reactogenicity of different i.v. medications in an occasional hypersensitive individual, has unique advantages compered to currently applied approaches of reactogenicity prediction. In particular, its high sensitivity reduces the risk of false negative result

Zymosan was established as a positive control. The end points are: Saturation, Heart Rate – HR, Temperature, End Tidal Co2 – ETCo2, Pulmonary Arterial Pressure – PAP, Cardiac Output – CO, Systemic Arterial Pressure – SAP, Systemic Vein Pressure – SVP, Left Ventricular End Diastolic Pressure – LVEDP.

 

CARPA model in domestic pigs is a platform for biomedical research of nanomedicine CARPA effects.

Orthopedic implants in sheep model

Dental Implants in minipig oral models

Pig Model of Neuropathic Pain Due To Sciatic Nerve Trauma

The pig is the ideal species for neuropathic pain studies due to the many similarities between pig and human. The large animal model for neuropathic pain presents biopharma companies with the opportunity to study in a more relevant model with fewer limitations on obtaining efficacy and PK data from the same animal. It is ideal for testing local therapies, slow release drug/device combinations as well as systemic therapies aimed at sciatica-related pain in humans. Sciatic nerve injury is created by partial ligation to the sciatic nerves with CFA coated sutures. This method provides a stable and controlled pain for at least 28 days. The model is suitable for a variety of therapies including local therapies to the nerve.

This model was developed together with MD Biosciences Innovalora Ltd.

 

The model has the following advantages:

  • Consistent and reproducible model involving both mechanical injury and inflammation.
  • There is no motor dysfunction avoiding the risk of secondary injury to the foot.
  • The method controls the area of innervation.
  • The pigs are sensitive to the feather test bringing further clinical relevance.
  • Morphine responds similar to what is seen in the clinic

Pig incision model of post‐operative pain.

Management of acute pain related to surgical intervention, termed post‐operative pain or POP, continues to be a major healthcare challenge. While the rat plantar incision model provides valuable data to researchers about the mechanisms mediating POP, the development of topical and localized treatments in small animal models is limited. To help address these issues, we have developed a large animal model of incisional pain.

The pig model of incisional pain can provide an appropriate translational model for validating new topical and localized treatments for POP in humans.

This model was developed together with MD Biosciences Innovalora Ltd.

Pig model for long-term Type I Diabetes.

Pig model for Obesity (minipigs).

STZ Induced Type I Diabetes Pig Model

STZ single and multi-systemic injection or selective injection to the pancreatic blood supply by Cath procedure. 1 month to 1 year diabetic pig model. The pig is useful as a model for human physiology and pathophysiology, because many organ systems resemble those of the human. Of special interest for the study of diabetes are the similarities to humans found in the clinical chemistry, nutrition and gastrointestinal tract, pancreas development morphology, and metabolism. These characteristics make swine an interesting species for studies of metabolic abnormalities in diabetes.

The model is relevant to efficacy diabetic and long-term diabetic complications drugs, medical device and combined products.

Pig model for Colitis

Pig model for post- surgical adhesion (peritoneal cavity)

A midline laparotomy is performed in order to expose the cecum. A surface on the peritoneum and on the cecum is gently abraded. The abdominal sidewall is sutured in order to create an ischemic area. Talc powder is spread on the abraded surfaces of cecum and peritoneum. Few days after the procedure the abdomen is opened carefully and cecum- peritoneum procedure is exposed and evaluated.

The advantage of the pig’s adhesions model is the organ size that are compatible with human organs size.  This model is an aggressive model for postsurgical adhesions suitable for evaluations of surgical anti- adhesion products.

Pig Model of Acute Wound Healing

The acute excisional wounds can be superficial, partial-thickness, or full-thickness.

Superficial wounds are made by repeated tape stripping, which removes only the stratum corneum and stratum granulosum. These wounds are excellent models to study the absorption of pharmaceutical and bandaging interventions and their effect on epidermal regeneration.

 Partial-thickness wounds are made by removal of the epidermis and variable amounts of dermis,

but usually leave the bases of the sebaceous glands and hair follicles intact. These excisions are frequently made with a dermatome;

Full-thickness wounds are made with a punch biopsy or scalpel by removal of the entire dermis down to the subcutaneous tissue or fascia; these wounds are optimal for inducing and studying hypertrophic scarring.

Pig skin has been shown to be the most similar to human skin structurally and biochemically.

Pigs are especially useful in wound healing and burn lesions studies due to the re-revitalization healing (as human) rather than by contraction (as rodent). Another advantage is the ability to use multiple wounds on the same animal which provides the ability to have the same animal serve as its own control and also to have different treatment on the same animal

Pig Model of Chronic Wound Healing

A full thickness wound 1.5cm x 1.5cm is incised and excised on both sides of the spine. Following excisions, doxorubicin is injected to the peripheral edges of the wounds. After few days, doxorubicin is reinjected to the peripheral edges of the wounds. From day 8 forwarded the wounds are checked daily for evaluation of the eschar formation on the wound. Treatment begin after all wounds developed eschar.

Pig skin has been shown to be the most similar to human skin structurally and biochemically.

Pigs are especially useful in wound healing and burn lesions studies due to the re-revitalization healing (as human) rather than by contraction (as rodent). Another advantage is the ability to use multiple wounds on the same animal which provides the ability to have the same animal serve as its own control and also to have different treatment on the same animal.

This model was used by companies to estimate the dose and treatment duration for maximal efficacy of eschar removal in chronic wounds.

Pig Model of Burns Using Radiant Heat

A 5 by 5 cm burns (deep partial thickness at the central and more superficial, partial thickness at the periphery) are created using a radiant healing device symmetrically on both sides of the pig adjacent to the vertebral spine. Immediately after burn infliction the burned epidermal layer consisting of keratin (which is equivalent to the “blisters” that normally form in humans) is gently wiped with soaked with saline saturated gauze.

The most accepted animal model for studying the healing of burns is the pig, due to the resemblance of its skin to that of humans. An advantage of this model is that the heating source does not come into direct contact with the animal, and the heat dispersion surrounding its center is relatively consistent in depth, size and location, therefore the effect of manipulation and burn treatment on wound healing outcome can easily accomplished. The model has been used by companies for the development of the enzymatic debridement agents.

Bedsores

Pig Model of Acute Heart Failure

The domestic pig is considered an ideal experimental choice to study human myocardial ischemia, due to size, vascular anatomy, ventricular performance and electrophysiology.

Open and closed-chest methods have been used for induction of MI in pigs. Open-chest (surgical) models have the advantage of easy access for precise control of site of occlusion and direct visual assessment of contractile function. To avoid the trauma associated with thoracotomy or sternotomy and its possible effects on cardiac function, several closed-chest techniques, mainly by means of percutaneous catheterization, have been developed. We have the ability to perform open chest and close chest models as regard to client request. Having all equipment and know how to make it reproduceable with Echo assessment, necropsy and histopathology. This model mainly used in new drug proof of concept trying to minimize myocardial damage.

Pig Model of Chronic Heart Failure

Left sided heart failure:

We are currently attempting to create a model of left sided chronic heart failure (CHF). Our methods are leading to a gradual and complete obstruction of the arteries and increased pre-load flow to the heart. The goal is to achieve a dilated left ventricle, with thinning of the ventricular walls and an enlarged mitral valve annulus resulting in Mitral regurgitation (MR).

The potential value of this model is that it will enable to supply animals suffering from left sided CHF to companies developing therapeutics indicated for treatment of left sided CHF, enlarged Mitral annulus and MR.

There are few successful models of CHF which do not result in acute death of the animals. Most of the existing models in large animals result in a high rate of acute mortality. All the procedures performed in the model are transcatheter. They do not require surgical opening of the chest, thus leaving the chest clean from adhesions when implanting test devices.

The establishment of this model in pigs will enable chronic evaluation of test devices in animal with comparable size and anatomy to humans (as opposed to rodent models). This will enable evaluation of efficacy of test devices, in addition to safety evaluation under pathological conditions

Equipment & Facilities

We offer cutting edge hospital-environment facilities and technology platforms to allow successful translation of pre-clinical assets to the clinical evaluation phase:

  • Four Operating Rooms include:
  • One Hybrid Catheterization Lab
  • Two Hybrid Operating Rooms including Fluoroscopy C-arm
  • One operating room for Non-Fluoroscopy procedure
  • One PM Lab
Operating Rooms including Fluoroscopy C-arm

Advanced imaging equipment: Fluoroscopy and Echo

Philips epic 7, TEE-3D

Siemens Acuson2000, ice, 3D

  • Laparoscopic / Cystoscopy system
  • Endoscopic Systems

 

Cardiopulmonary Bypass Equipment

Image Guided Procedures:

Karl Storz Laparoscopic System

Olympus Endoscopy System

Karl Storz Cystoscope

monitor view
procedure heart

Acclimation and follow up unit:

  • Acclimation and preparation of the animal for the medical procedure
  • Post procedure treatment and follow-up

Blood separation & skin preparation lab

 

Meeting Rooms:

  • Meeting rooms with live case capabilities
  • Lecture halls for the teaching sessions

 and much more .

meeting room

Best Practice

Our work follows the best practice in the world of medical research,  verified and certified by:

ISO-9001-2015

Quality and Service

All facilities and activities are approved and monitored in accordance with ISO9001 (2008) standards for quality and service.

GLP_logo

Good Laboratory Practice

Perform & ensure tests with uniformity, reliability and reproducibility

ministry of health

Ethics

All research studies are coordinated and approved by the national ethics committee of Israel.

Confidentiality and Security

With health care and other sectors moves from paper to electronic data collection (RAW), providing easier access and data management, we are committed for your confidentiality and security, protecting of ‘ privacy interests against appropriate information access.

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