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Drug Development and Microcirculation
Perimed is the world leader in advanced instruments for peripheral vascular diagnosis. Our core competencies in microcirculation and the effects thereof makes us a qualified partner for Contract Research Organizations (CRO) and similar for clinical and pre-clinical studies.
When conducting clinical studies, especially when conducting them in multiple geographical locations, it is of utmost importance to work with instruments that provide accurate, reliable and reproducible results. Perimed is proud of providing instruments with standardized measurement procedures equipped with customized workflow in order to best fit the study at hand.
Perimed’s products are used by Contract Research Organizations (CRO’s) around the world. The research varies from deep pre-clinical studies of cerebral blood flow in Middle Cerebral Artery Occlusion (MCAO) models to microcirculatory function in human skin and drug development to improve ulcer healing and perfusion.
Microcirculation assessment with PeriFlux 6000
The PeriFlux 6000 Combined System offers the unique capability to simultaneously assess both Toe Pressure and PVR as well as measure Transcutaneous Oxygen in the tissue with one and the same system. The standardized accurate measurement procedure and the ability to customize workflows makes this instrument highly qualified for studies involving drug development where microcirculation and the effects thereof are of importance.
In clinical as well as preclinical research, PeriFlux 6000 offers several advantages:
- Thermostatic Laser Doppler probes for up to 6 channels
- Transcutaneous Oxygen (tcpO2) for up to 5 channels
- Fast simultaneous bilateral examinations
- Time-saving parallel assessment
- Probes heated to 40 degrees C (104 degrees F) for increased sensitivity
- Standardized measurement procedure for comparative results
- Customized workflow, personalized reports and audit logs
- HIPAA compliant
Microcirculation imaging for drug development
Perimed was the first company to commercialize laser-based microcirculation imaging and has over the past 40 years been the world leader in perfecting those techniques.
PeriCam PSI, based on the Laser Speckle Contrast Analysis (aka LASCA or LSCI), is a powerful tool for studying microcirculation in real time. It both visualizes and quantifies the perfusion in the tissue with a high resolution and frame rates op to over 100 images/second. This enables studying dynamic responses in real time including 2-dimensional responses such as a flare reaction.
Perimed’s microcirculation imagers have been in use by contract research organizations (CRO’s) for drug development research for many years and have been proven to be a valuable tool in a repeatable, non-invasive pharmacodynamic model [ref 1]. This model was successfully used in several clinical studies [ref 2,3]. The same center showed that the new PeriCam PSI is even better suited for this model due to its speed and higher reproducibility [ref 4]. Another center used PeriCam PSI in a model for drug development [ref 5] and recently published a clinical study that applied this model [ref 6].
The PeriCam PSI is also ideal for preclinical research (animal models). See for example our pages on stroke model and hind limb ischemia.
In clinical as well as preclinical research, PeriCam PSI offers several advantages:
- Non-invasive
- No contact with patient needed
- No need for injectable contrast agents
- No ionizing radiation
- Ease of use
- Intuitive and powerful software for measurement setup, recording and analysis
- Small format system offers great flexibility in busy and crowded environments
- Easy to position due to flexible arm and ball head mount.
- Fast
- Real time imaging: up to ~100 images per second
The PeriFlux 6000 and Pericam PSI Imaging system are clinically approved in the USA, Europe, China and many other markets.
References:
- Van der Schueren, B.J., De Hoon, J.N., Vanmolkot, F.H., Van Hecken, A., Depre, M., Kane, S.A., De Lepeleire, I. and Sinclair, S.R. (2007), Reproducibility of the capsaicin‐induced dermal blood flow response as assessed by laser Doppler perfusion imaging. British Journal of Clinical Pharmacology, 64: 580-590. doi: 10.1111/j.1365-2125.2007.02939.x
- Monteith D, Collins EC, Vandermeulen C, Van Hecken A, Raddad E, Scherer JC, Grayzel D, Schuetz TJ and de Hoon J (2017) Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the CGRP Binding Monoclonal Antibody LY2951742 (Galcanezumab) in Healthy Volunteers. Front. Pharmacol. 8:740. doi: 10.3389/fphar.2017.00740
- de Hoon, J., Van Hecken, A., Vandermeulen, C., Yan, L., Smith, B., Chen, J.S., Bautista, E., Hamilton, L., Waksman, J., Vu, T. and Vargas, G. (2018), Phase I, Randomized, Double‐blind, Placebo‐controlled, Single‐dose, and Multiple‐dose Studies of Erenumab in Healthy Subjects and Patients With Migraine. Clin. Pharmacol. Ther., 103: 815-825. doi: 10.1002/cpt.799
- Dorien Bamps, Laura Macours, Linde Buntinx, Jan de Hoon, Laser speckle contrast imaging, the future DBF imaging technique for TRP target engagement biomarker assays, Microvascular Research 129, 103965
- van der Kolk, T., Assil, S., Rijneveld, R., Klaassen, E.S., Feiss, G., Florencia, E., Prens, E.P., Burggraaf, J., Moerland, M., Rissmann, R. and van Doorn, M.B. (2018), Comprehensive, Multimodal Characterization of an Imiquimod‐Induced Human Skin Inflammation Model for Drug Development. Clinical And Translational Science, 11: 607-615. doi: 10.1111/cts.12563
- Niemeyer‐van der Kolk, T., Assil, S., Buters, T.P., Rijsbergen, M., Klaassen, E.S., Feiss, G., Florencia, E., Prens, E.P., Burggraaf, J., van Doorn, M.B., Rissmann, R. and Moerland, M. (2020), Omiganan Enhances Imiquimod‐Induced Inflammatory Responses in Skin of Healthy Volunteers. Clin Transl Sci, 13: 573-579. doi: 10.1111/cts.12741
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